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Unraveling Regulatory Reporting: Importance & Challenges of Chemical Inventory Reporting

Whether you work at a sprawling biotech complex or a bustling academic lab, we can all agree – accurate chemical inventory reporting is crucial for transparency, accountability, and regulatory compliance.

Unfortunately, such reporting can be one of the most tedious aspects of the job.

In part 1 of this series, we looked at why complying with fire codes and maximum allowable quantities (MAQs) is so challenging. (If you missed that article, you can find it here.)

Now we're going to dive into the role of regulatory reporting, including Tier II/Right-to-Know (RTK), and take a closer look at the challenges faced by commercial and university labs in reconciling their chemical inventory reporting.

What is regulatory reporting?

Regulatory reporting is the process of compiling, verifying, and submitting data to regulatory bodies. In the US, life sciences, pharmaceutical, academic, and biotech labs are often required to report on their chemical inventories to various regulatory bodies. These include state and local authorities, as well the United States Environmental Protection Agency (EPA).

What is the role of regulatory reporting, and why is it important to labs?

Regulatory reporting plays an important role in maintaining safety standards within laboratories handling hazardous materials.

Imagine a pharmaceutical lab that regularly handles volatile chemicals as part of its research and development activities. The lab maintains detailed records of the types, quantities, and locations of these hazardous materials for regulatory reporting.

This information is crucial to make sure that the quantities of chemicals stored stay within safe limits, reducing the risk of accidents or exposure to harmful substances.

Accurate reporting also enables the lab to track potential hazards, such as flammable or reactive materials, and enforce compliance with fire safety regulations. And, in the event of an emergency, the information in these reports provides lab personnel, emergency responders, and community stakeholders with essential information about hazardous chemicals present in the facility.

Maintaining detailed records, quantities, and locations for hazardous materialsis crucial for regulatory reporting.

What is TierII/Right-to-Know (RTK)?

Among the various types of regulatory reports, Tier II/Right-to-Know (RTK) reports hold particular significance for labs.

Under the Emergency Planning and Community Right-to-Know Act (EPCRA), facilities in the US are required to submit annual reports on the storage and use of hazardous chemicals above certain threshold quantities. The information in these reports enables emergency responders, local authorities, and the public to prepare for and respond to chemical emergencies.

Tier II reports typically include details such as the name and quantity of each hazardous chemical stored onsite, its location within the facility, and any associated hazards. RTK, or Right-to-Know, refers to the provision that allows any citizen to request access to this information.

What are the challenges of regulatory reporting for labs?

Despite the critical importance of regulatory reporting for researchers, first responders, and communities, labs encounter unique challenges in managing and reconciling their chemical inventory data for reporting.

1. Keep your chemical inventory up-to-date

One of the most basic challenges for labs is the sheer volume and complexity of chemical inventory data that they must track, manage, and report. A single facility may house hundreds of chemicals, each with its own storage and reporting requirements. With chemicals constantly being received, used, and disposed of, managing all the moving pieces can sometimes feel like herding cats.

With space at a premium, researchers sometimes resort to “creative” storage solutions like stashing samples in hallways, breakrooms, and broom closets. In a recent SciSure webinar, Sarah Eck, PE, CCPSC, Sr Process Safety Engineer, DEKRA North America, said she's seen everything from flammable solvents shoved in regular cabinets to boxes labeled “refrigeration required” tucked away under a table because someone didn’t know where to put it. Add to that items that get left in the receiving room or forgotten because they were sent to the wrong building — along with non-lab spaces like janitor closets — and simply knowing what you have on hand is a full-time job.

2.  Tracking the location of chemicals within your facility

In addition to knowing what chemicals you have on hand; you'll also need to know where chemicals are located within your facility. This is necessary to produce reliable regulatory reports for Tier II/RTK and fire code compliance.

If you're calculating totals toward MAQs, for example, you need to be able to report on all the chemicals within a control area or zone.

This is especially challenging when you have multiple lab groups operating in shared spaces. “Rarely does a single researcher have that zone all to themselves,” explained Jeffrey Foisel, R&D Lab Process Safety Technology Leader at the Dow Chemical Company, in a recent SciSure webinar.

Having a centralized chemical inventory system that can locate all the chemicals on hand that fall under a specific regulation — regardless of which lab group they belong to — and generate reliable reports at the aggregate unit becomes crucial to streamline your reporting processes.

3.  Staying on top of changing regulations

As we discussed in our fire code compliance article, reporting requirements can be complex and vary based on factors such as the type of chemicals used, the volume of chemicals stored, and the regulations in your jurisdiction. For example, NFPA and IBC/IFC have different MAQ limits and different methods for calculating these limits.

To make matters more complicated, different states and regulatory agencies may have different reporting formats and submission requirements, adding to the complexity for labs. In California, for example, facilities subject to Tier II/RTK reporting are required to submit their chemical inventory data electronically through the CERS platform.

Without a real-time chemical inventory reporting solution, labs may struggle to ensure accuracy and consistency across all their evolving reporting obligations.

4.  Compiling and formatting data for reporting

Traditional methods of regulatory reporting often involve manual data collection, entry, and calculations, which can be time-consuming and error-prone.

Let's say you need to compile a Tier II/RTK report. Unless you have regulatory reporting software like SciSure in place, you might begin by reviewing your purchase and disposal records to identify all reportable chemicals present in the facility.

Then, you would need to gather information about each chemical, including its name, quantity, storage location, and associated hazards. You’d most likely have to perform some pretty complicated calculations before organizing this information into the required format, which typically includes filling out a standardized reporting form or submitting data electronically through a designated portal.

Finally, you’ll need to double-check that all required fields are accurately completed — and cross your fingers that you haven’t made any mistakes — before hitting “Submit”.

5.  Allocating time and personnel for reporting

EHS and Lab Ops teams juggle so many different tasks and responsibilities, leaving little time and resources for regulatory reporting. This can lead to delays or oversights in reporting tasks.

For instance, picture a research lab at a small university. The lab may have a dedicated researcher who is also responsible for regulatory compliance tasks, such as chemical inventory reporting. However, because the researcher's primary focus is on conducting experiments, they may struggle to find time to fulfill reporting requirements.

As a result, reporting tasks might be delayed or overlooked, leading to non-compliance with regulatory deadlines and requirements.

While you likely can't afford an extra FTE to handle these tasks, a chemical inventory reporting solution like SciSure can reduce the time spent on tasks like managing inventory and reporting by as much as 80% — freeing scientists up to focus on their research.

Reduce the time spent on tasks by more than 80%automating inventory management and regulatory reporting

What are the risk of inaccurate chemical inventory reporting?

The consequences of failed audits and non-compliance with regulatory reporting requirements can be severe, ranging from fines and penalties to reputational damage and legal liabilities. What's more, inaccurate or incomplete reporting can hinder emergency response efforts, putting both facility personnel and first responders at risk in the event of a fire or chemical emergency.

But don’t take our word for it. Here are some statistics that underscore the importance of accurate chemical inventory reporting:

• In 2022, local fire departments in the US responded to approximately 5 million fires, with about 9% occurring in nonresidential structures. Nonresidential fires resulted in 150 civilian deaths, 1,400 injuries, and $4 billion in property damage.
• Hazardous materials accounted for 433,500 fire department calls in 2022. (Source: NFPA)
• Consequences of fire code violations vary by state. Here in Massachusetts, for example, repeat offenders may face fines of at least $1,000 and/or jail time of at least one year. (Source: Massachusetts Legislature)
• The EPA imposed nearly $250,000 in fines for violations related to Tier II reporting in 2018. (Source: EHS Daily Advisor)
• The majority of Tier II violations involve a handful of chemicals commonly found in labs, such as sulfuric acid and ammonia. (Source: JD Supra)
• The EPA is in the process of hiring more than 300 new inspectors, attorneys, and technical staff to conduct more inspections and enforcement in the coming year. (Source: US EPA)

Your takeaway

Given the risks and challenges of regulatory compliance and reporting, accurate and timely chemical inventory reporting is an urgent priority. By embracing innovative tools and best practices, labs can mitigate risks, enhance safety, and focus on their core mission of scientific discovery.

In the third part of this series, we'll show you how real-time reporting solutions can enhance compliance and streamline your reporting processes.

In the lab software space, the smoke is starting to clear.

And what I've seen isn't pretty; it's the aftermath of failed implementation of electronic lab notebooks (ELN) or laboratory information management systems (LIMS) that don't fit the needs of Biotech and BioPharma laboratories.

On one extreme, I see classic Silicon Valley tech software organizations focused more on pretty user interfaces (UI) than truly valuable lab workflow management. Conversely, I see function-heavy, extremely technical, but non-user-friendly software, limiting adoption and use. The rise of AI/ML in drug discovery has further complicated the landscape, with scientists' attention diversifying, adding additional difficulties in the decision-making process of which laboratory software platform to use.

Overall, these problems are related to a common issue: the lack of a holistic approach to a lab's core challenges.

The Solution: A Sample and Digital Strategy

We at  SciSure (formerly eLabNext) are prepared with a solution, a new concept and approach called "Sample and Digital Strategy."

A sample is the focal point of any lab, whether cell lines, antibodies, plasmids, blood, DNA, RNA, protein, or a mouse colony. Everything starts with a sample! This sample has metadata attached to it and file outputs from your instruments, all of which can amount to millions of datasets, also known as a deep data lake.

If you do not have a strategy for efficiently managing this data and making it accessible to all of your departments, you are at risk of data loss and potential loss of IP, a victim of poor business strategy decisions. In other words, Sample and Digital Strategy is foundational in defining the lab's business strategy and ultimately picking the right software to fit your lab's needs.

5 Easy Steps to Implementing a Sample and Digital Strategy

If all of this sounds a little too familiar, it's likely time to transition away from your current software solution and one that allows the implementation of a Sample and Digital Strategy. Here's a step-by-step process for identifying a better solution for you.

Step #1: Define your Sample Strategy

Get your Sample Strategy in order. That means:

• Consolidate your freezers and samples and use this time as an opportunity for spring cleaning, both physically and digitally. You probably have random unlabeled samples lying around; claim or toss them.
• Clean up your Excel sheets!
• Export the data out of old-school software or the currently problematic ones! Organize it, make your data structured, and prep it for import into a new system!
• Consider following the guidelines provided by our #Sample360 initiative!

Step #2: Define your Digital Lab Strategy

We talk about Business Strategy. We discuss Research and IP strategy. But we hardly discuss Digital Strategy.

These days, you cannot have sustainable operations and a sustainable lab workflow if there isn't a robust digital strategy defined right from the beginning for the lab. Within the next five years, AI and ML will completely revolutionize how we analyze our data, and if you do not start structuring your data now, you'll fall behind. We can help you with defined steps on how to centralize your data and develop naming conventions, search, and accessibility prompts to structure your data and grow into your workflow rather than outgrow it as soon as the number of samples increases.

Find out more about how Bayer is doing this now with SciSure!

Step #3: Prepare for Technical Transition

Prepping technically means not just diving in and releasing new software on your staff. Take a logical and strategic approach:

First, identify the tech-savvy champions on your team that will lead this project.

1. First, identify the tech-savvy champions on your team that will lead this project.
2. Prepare and organize the list of your storage units (e.g., freezers, shelves, racks, etc.) and equipment (e.g., balances, HPLCs, mass specs, etc.).
3. Prepare a list of all your samples and supplies.
4. Make sure your Excel files are standardized and clean.
5. Define a project/program and experiment naming convention if you haven't already. 
6. Identify all other software currently used in the lab for potential integrations.

Step #4: Prepare for Training

Prepare your team for Digital Strategy Training. That means doing the following:

• Assess the existing skillset and identify the folks that have expertise in implementing new technology, and most importantly, those that are resistant to change.
• Develop a training plan.
• Choose the right trainers and make sure that your Digital Lab Consultant (if you've hired one) is someone you enjoy working with!
• Provide hands-on experience and lead by example! You can't promote lab digitization if you aren't digitized yourself.
• Foster a culture of continuous learning. Once the training is done, learning doesn't end. With software and digital solution implementations, there are constantly new updates, new features, and creative ways to optimize your physical lab workflows. Find out more about efficient implementation here.
• Measure your lab's progress and outcomes.

Step #5: Set Deadlines for Implementation and Transition

Set deadlines, or else it'll be a never-ending project. Digital and Sample Strategies need a strong foundation, but it also needs to be cultivated constantly. For the initial kickoff of implementing new ways of doing science, it is necessary to set expectations for the whole lab and the company, communicate them effectively, and execute professionally. This will help ensure adoption success.

Spring has Sprung: A Spring Cleaning Announcement

We are currently offering a special Spring Cleaning discount for anyone who wants to transition from their problematic ELN/LIMS. This special includes:

• 1,000 sample free Import
• Free Import of all Equipment
• Free Import of all Supplies
• Free Digital and Sample Strategy consultation and training
• Start-up discount for labs that have less than ten people

If you're interested, contact us here.

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As technology continues to evolve, it's crucial for researchers and institutions to stay adaptable. With the rise of digitization in the business world, the debate over paper documents versus digital or electronic lab notebooks persists.

So, let's take a deeper look at both approaches to understand the value each could bring to your research. The integration of ELNs represents a step toward a more interconnected, efficient, and collaborative future in scientific exploration. The use of electronic laboratory notebooks in laboratories is growing as laboratories strive for higher quality due to the volume, complexity, accessibility, and security requirements.

Whether recorded on paper or in pixels, the pursuit of knowledge remains at the forefront, driving laboratories to innovate in their record-keeping practices.

Let's delve into the common reasons behind the continued use of paper notebooks and explore why many laboratories are making the shift to electronic solutions in the modern era.

The Charm of Paper

Simplicity and Tangibility

There's a perceived satisfaction in flipping through pages and jotting down notes with a pen. Paper notebooks offer a straightforward and tangible way to record experimental details.

Minimal Learning Curve

Researchers, especially those accustomed to traditional methods, may find it easier to stick with paper due to its minimal learning curve — no need to adapt to digital interfaces.

Security Concerns

Some scientists express reservations about the security of digital data. Paper notebooks are perceived as less susceptible to cyber threats, providing a sense of control over sensitive information.

Universal Accessibility

A paper notebook doesn't rely on electricity or devices. It's universally accessible, which can be advantageous when technology is not readily available.

Efficient Organisation and Searchability

ELNs are based on FAIR Principles (Findable, Accessible, Interoperable, Reusable), which are recognized by the research community. It empowers researchers with tools for efficient data organization and searchability. Finding specific experiments or data becomes a breeze, saving valuable time in the research process.

Collaboration and Sharing

Digital notebooks facilitate seamless collaboration. Researchers can share data in real-time, transcending physical boundaries. This interconnectedness enhances teamwork and accelerates the pace of scientific discovery.

An ELN facilitates global collaboration; this is especially true where outsourcing agreements have been set up so that different laboratory capabilities can be made use of. Integrating ELNs with a multivendor informatics architecture will streamline data capture and analysis workflows, thus enhancing the efficiency and accuracy of data management. An ELN enables real-time collaboration in research projects because it draws on the different expertise of laboratories and scientists. It sets clear and standardized communication parameters - usually through a real-time platform. This ensures all communications regarding an experiment are kept in context and are always linked to their source. Because it allows you to connect all interactions and notes to their relevant data, an ELN contains the 'story' behind the information and protects it for easy retrieval in the future.

Integration with other research applications

ELNs can be integrated with secure cloud-based communal repositories like Mendeley, SciSure (formerly eLabNext) AI Protocol Generator, and other applications, making publishing, information accessibility, and the research process easier.

This integration streamlines data capture and analysis workflows.

Workflow automation

Workflow automation makes it convenient for scientists to stay on top of their assignments, automating, securing, and linking critical files to an experiment. In addition to pre-populated standard operating procedures (SOPs) templates, users can create complete experiment templates to save time starting from scratch.

Our LIMS capabilities helps you to store data using inventory tracking systems. It can also be used to automate tasks related to inventory control, such as logistics, ordering, and shipping so that labs can stay on top of material usage during their many experiments or production processes. These features enhance the efficiency of ELNs and help reduce costs.

Version control and data integrity

ELNs often come equipped with version control features, ensuring that every iteration of an experiment is documented. This helps maintain data integrity and provides a clear audit trail for all research activities.

Digital documents don't get damaged and lost

Unlike paper documents, electronic lab notebooks do not wear or fade with time; you can actually read the text and are not reliant on expert handwriting analysis. Most importantly, ELNs do not occupy physical space and cannot get easily misplaced or somehow 'lost in transit' between two points or between individuals.

Better record-keeping and compliance

ELNs automatically record each entry's user name, date and time, providing an audit trail of project progress and enabling compliance with regulatory requirements. Removes insecure transmissions

Rather than sending documents via email with the associated risk of security breaches, the ELN offers an online portal storing documents on a secure website.

Environmental Considerations

In an era where sustainability is a priority, opting for electronic solutions reduces paper and cardboard usage. This aligns with broader efforts within the scientific community to adopt eco-friendly practices. Although there is an initial investment in implementing ELN software, it leads to long-term cost savings by reducing the need for paper, ink, printers, storage space, and administrative resources associated with paper-based notebooks.

Striking the Balance

In the end, the choice between paper and electronic lab notebooks isn't a one-size-fits-all decision. Laboratories must strike a balance that aligns with their specific needs and the preferences of their researchers. While some may hold onto the nostalgic charm of paper for a little longer, others recognize the undeniable advantages that digital solutions bring to the modern laboratory.

Ultimately, the decision between a paper and electronic lab notebook depends on the specific needs and preferences of the research team, as well as considerations such as budget, security requirements, and institutional policies. Many modern research institutions are increasingly adopting electronic solutions due to their enhanced collaboration capabilities and integration with other digital tools.

Overall, electronic lab notebooks offer a modern, efficient, integrated, documented, and secure solution for managing research data, fostering collaboration, and advancing scientific discovery in various fields.

Find out how the SciSure can benefit your lab by scheduling a free demo today!

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RFID: A Leap in Lab Safety & Inventory Control

In the world of laboratory management, efficiency, cost management, safety, and compliance aren't just goals; they're necessities. How you manage your chemical inventory can significantly impact these crucial aspects. That's where RFID (Radio Frequency Identification) technology steps in, revolutionizing how labs handle chemical inventory management. In this article, we'll dive into how RFID technology tackles common inventory challenges and pairs seamlessly with robust inventory management software to provide customized solutions.

93% of North American companies using RFID technology for inventory tracking, reporting a 10% ROI.

Safety Compliance: A Top Priority

The cornerstone of any lab environment is safety and compliance. But improved compliance is more than just keeping tabs on chemicals. It's about staying within regulatory limits and ensuring that reagents are stored in controlled environments, in line with OSHA’s standards.

One frequent error in the management of chemical inventories is the failure to update records when chemicals are consumed or discarded, leading to overreporting. This is where RFID technology shines. It ensures accurate tracking of chemicals, aiding labs in staying compliant with OSHA's Hazard Communication Standard (HCS). Integrating RFID into a chemical inventory tool makes compliance not just a goal but a seamless part of your lab’s daily operations.

Boosting Efficiencies: Beyond the Basics

Efficiency in a lab isn’t just about speed; it's about accuracy and real-time tracking. RFID technology allows for monitoring containers from 'active' to 'disposed,' optimizing purchasing, reducing waste, and improving emergency response times.

Accurate labeling of chemicals is crucial. It informs lab personnel about potential hazards, prevents the generation of unknown substances, and facilitates quick emergency responses. Knowing the location and quantity of your chemical containers is an HCS requirement, and real-time inventory tracking with RFID technology makes this process more efficient than manual labeling methods, which are often riddled with inefficiencies and transcription errors.

On average, companies that adopt RFID see their inventory accuracy go from 63% to 95%.

Cutting Costs, Not Corners

With RFID, completing inventory counts can become 100 times faster. With the hourly cost of FTEs, the potential savings are enormous. As RFID usage grows across industries, its cost has reduced significantly, making it an increasingly accessible option for labs of all sizes.

When it comes to managing laboratory spend, RFID technology offers unparalleled productivity and cost-effectiveness. Implementing RFID technology increases inventory count rates exponentially, leading to significant time and cost savings. This transition aligns with the economic analysis of the HCS, which suggests that the updates result in net cost savings, thereby providing a financially viable solution for labs.

Understanding Risk and Solutions

Expanding our educational approach is crucial to help the industry comprehend the risks associated with unlabeled and unaccounted for chemicals in the lab. The inconvenience of unlabeled containers today far outweighs the transition to RFID technology. It's not just a technology shift; it's a paradigm shift toward better safety, efficiency, and compliance.

Most Common Risks of Poor Chemical Inventory Management Safety Hazards | Audit Findings | Monetary Loss

Decisions Based on Facts

The integration of RFID technology in laboratory settings significantly contributes to fulfilling the requirements of OSHA's HCS, enhancing the safety, efficiency, and compliance.

RFID technology isn't just a tool; it's a game-changer in the realm of laboratory management. By addressing safety, efficiency, and spending concerns, RFID empowers labs to focus on what they do best – groundbreaking research and innovation. Don't let outdated inventory methods hold your lab back. Embrace RFID technology and step into a future of streamlined, safe, and efficient laboratory management.

Getting Started with RFID

To fully grasp how RFID can transform your lab’s inventory management, schedule a demo with an expert at SciSure. We offer tailored solutions that address the unique needs of your lab, ensuring that you're not just meeting standards but also setting new ones.

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There was a time not too long ago when the only biotech incubators out there were LabCentral and BioLabs.

But a lot has changed. The life science industry, including big pharma, has become more flexible, allowing young, ambitious, and innovative companies to flourish and grow. Incubators have been pivotal in creating this thriving ecosystem, and there are hundreds of facilities and coworking spaces that cater to the unique needs of biotech startups, including  SmartLabs, CIC, Alexandria LaunchLabs, Harvard Innovations Lab, Greentown Labs to InnoLabs, Cure Innovations Lab, MBI, and more. Large pharma has done the same with Bayer’s Co.Lab, BMS’s Thomas O. Daniel research incubator and collaboration center, and J&J’s JLABS.

With so many players in the biotech incubation scene, it can be challenging for newcomers to distinguish themselves. That said, one incubator that spun out of MIT, The Engine, has experienced significant success by focusing its efforts on companies in the “Tough Tech” industry. In this area, cutting-edge science is deployed to solve the world’s most significant problems. This niche concentration has enabled The Engine to attract and nurture some of the most fascinating disruptors in the industry, all under a single roof.

To get a glimpse “under the hood” of The Engine, I sat down with their Business Development Manager and hardcore Boston Celtics fan, Hayden McFarlane, to learn more about what makes them unique and how they foster the next generation of Tough Tech disruptors. 

Q: What is the difference between a traditional biotech coworking space and The Engine accelerator? What makes The Engine special and unique?

A: At The Engine Accelerator, we focus on being the home of  “Tough Tech”. This is reflected in how we’ve structured our spaces, where we have 3D printing labs, electronics labs, machine shops, dry lab spaces, as well as BSL-2 biology and chemistry labs.

What makes us different is that we sit at the convergence of Science and Engineering. This means that teams could be in the labs pipetting in the morning, then in our fabrication space doing 3D printing over lunch, and by afternoon, they’re fabricating prototypes with our Super Mini Mill.

The machine room is a shared space with 3D printers, allowing companies to reserve equipment time for creating necessary pieces without outsourcing or investing in rarely used equipment.

The Engine comprises biology and chemistry labs, along with a range of shared lab spaces and lab suites available for rent. These facilities are equipped with diverse equipment to meet the research needs of various companies.

Q: Why would a young start-up want to be part of an incubator instead of getting their own lab/office space?

A: It boils down to making the most of your money early in your Tough Tech journey. As a true accelerator, we provide equipment, permitting, utilities, facilities, etc. This makes it easier for the startup to concentrate on de-risking their science or tech as quickly as possible.

Q: Is there a limit to how long a company can remain at The Engine or how big their group can get?

A: We built the space with the growth of our residents in mind. Teams can lease a single wet lab bench and grow into a private 60-bench lab over their growth cycle. Because of this, we do not impose time limits. Part of the rationale behind that is that we are operating in the Tough Tech world, where teams are tackling the toughest challenges in the world. It’s impossible to put a time limit on when a company will solve something like that.

Q: How did the pandemic shape the incubator business model generally and The Engine’s culture specifically?

A: Teams are now more interested in the hybrid model and letting staff work from home when they can. Obviously, that's impossible for lab workers, and with that in mind, we structured our building to be 66% lab space so if another pandemic were to hit, our most usable space would still be in play.

Q: What are the top 5 industries or sciences represented at The Engine, and is there a particular type of resident you’re looking for?

A: Climate change, human health, and advanced systems and infrastructure are the primary 3 industries our residents work in. We have some residents who work in food or agri-tech, but they have some overlap with climate change and human health. We typically search for founders whose breakthroughs will make impactful changes in society and those who may disrupt their industry over the next 30-plus years.

Q: So you are looking for industry disruptors! What defines a disruptor, and how does The Engine ecosystem promote or support this?

A: A disruptor is typically the founder with industry-changing ideas. It's easy to focus on the tech, but the person driving the tech and the team behind it is the disruptor. We find the disruptors through various onsite programming, including our Blueprint Program aimed at postdocs and research scientists who have developed great ideas. We have created a massive ecosystem over the last 7 years that tends to attract these types of founders. The Engine Accelerator’s infrastructure, programs, and network uniquely help disruptive founders bridge the gap from their breakthrough to commercial viability and scale.

Q: What is Tough Tech? How does it differ from biotech, and how will it transform the industry and the world?

A: Tough Tech is a transformational technology that will change the world for the better but requires time and complex solutions to reach commercial viability, potentially spanning the course of years or even decades. Things like fusion energy, carbon capture, battery tech, cell therapies, quantum computing, and so much more. All of these things will help slow down some of the global issues, such as climate change, we are collectively dealing with.

Q: What are the challenges in running The Engine?

A: I think one of the biggest challenges is raising awareness about what The Engine offers. Many people mistakenly think you have to come from MIT or be invested in by The Engine Ventures to be part of it. However, 750 Main St is a home for ALL tough tech founders. Additionally, teams need to move quickly but with precision. Often, the infrastructure needs they had when they moved in have changed. We work with teams to ensure they can effectively scale their operations without losing time or capital.

Q: What is the screening process for new residents like?

A: We have a process for evaluating if a team is truly a “Tough Tech” project, and from there, it's a relatively streamlined process of EHS forms, etc. The process starts with filling out our Space Inquiry Form and can take 2 -6 weeks for our team to review and get the company into the space, depending on the team's infrastructure needs.

Q: In 3 words, how would you describe The Engine?

A: Three words is an injustice for a place that houses 90+ teams working on world-changing technologies! But I would say - Inspiring, Dynamic, & Transformative.

Q: How should people get in touch with The Engine if they want to take space here?

A: They can apply on the website www.engine.xyz or email me at hayden@engine.xyz.

The Factors that Keep The Engine Running

I’ve spent countless hours at The Engine for panel discussions, fun events, informative demonstrations, training, or pitching, and 3 unique threads make it such a special place!

First, the infrastructure, interior design, and architecture perfectly balance privacy and collaboration. You can isolate yourself, concentrate and power through complex projects, and at the same time, find a moment to brainstorm with colleagues and other companies to extract a deeper understanding of your tasks.

Second, the ecosystem is genuinely inspiring due to the extremely high application standards, which attract some of the most fascinating companies and talents into the space. See what it means to “Turn tough tech breakthroughs into Tough Tech startups” here.

Finally, the access to instruments and digital technologies and support from the staff make The Engine a valuable place for startups. The Engine stands out in the bustling world of biotech incubators by embracing 'Tough Tech' and providing a dynamic space where disruptive ideas and groundbreaking science collide, all in an inspiring, dynamic, and transformative ecosystem.

SciSure is proud to partner with The Engine. Our collaboration underscores our commitment to supporting innovative startups as they navigate the challenges of launching their ventures. Together, we've worked closely to ensure that startups have access to the tools, resources, and expertise they need to succeed, fostering an environment where ambitious entrepreneurs can thrive.

To learn more, visit engine.xyz.

Biosafety training, which comprises numerous elements that make up biosafety (e.g., bloodborne pathogens training, emergency preparedness and response training, biohazardous waste training, etc.) is essential for anyone working in a research laboratory that works with a variety of biological agents. It equips personnel with knowledge and skills necessary to handle biological materials safely and responsibly. These types of training are intended to protect the health and well-being of laboratory personnel, the broader community, and the environment.

What are the Goals of Biosafety Training?

Biosafety training has several key goals, but the priority is to reduce the risks of biological agents through awareness and work practices:

• Communicate containment measures associated with biological risk groups and biosafety levels.
  • Awareness of biological agents may be the utmost important aspect of biosafety training. Biological agents are classified according to their risk level when considering infectivity, pathogenicity and availability of preventive measures and treatments for the corresponding disease. Based on the biosafety risk assessment and biological agents, specific biosafety levels (BSL-1 to BSL-4) are designated, each with increasingly stringent containment requirements. It’s important to conduct biosafety assessments to understand the types of hazards that may be encountered.
• Educate laboratory personnel on safe practices for handling biological materials and the prevention of laboratory acquired infections.
  • Biosafety training equips laboratory personnel with the specific knowledge and skills needed to work safely with biological agents. Laboratory-acquired infections are a significant threat to lab personnel. Biosafety training is a control in minimizing the risk of laboratory acquired infections by emphasizing safe work practices. Training topics include hand hygiene, sharps and needle handling, proper handling techniques for biological materials to reduce the risk of exposure, decontamination procedures, and waste disposal practices.
• Ensure compliance with regulations.
  • Research involving biological agents is subject to several regulations (e.g., blood borne pathogens, infectious waste management, biomedical waste, transportation, etc.). Biosafety training informs relevant personnel to adhere to these regulations to prevent non-compliance, and more importantly - exposure to a deleterious agent. It’s important that a compliance register is maintained and updated to stay ahead of new or changing regulations.

What are the Key Components of Biosafety Training?

Effective biosafety training covers several crucial components:

• Laboratory Design and Biocontainment Controls: Engineering controls, such as controlled access, biosafety cabinets (BSCs), and ventilation systems, minimize biohazard risks. Sealed containers/secondary containers to contain biological materials and prevent exposures are equally critical.
  • Engineering controls that maintain a safe research environment are critical systems. Engineering controls, such as how ventilation systems maintain negative pressure rooms so contaminated air doesn’t reach common work areas, are vitally important for reducing the risk of exposure to airborne biohazardous contaminants.
  • The BSC is designed to reduce the potential escape of biological material into the worker's environment and to remove contaminants from the research work zone. There are different classes of BSCs and the selection of the class is dependent on the types of biological agents being handled. BSCs must be tested and certified. Biohazardous waste disposal and handling should be included, as well.
• Personal Protective Equipment (PPE): Training instructs personnel on proper selection, use, maintenance, and disposal of PPE to ensure optimal protection against biohazards.
  • PPE serves as a last line of defense against biohazards. Biosafety training focuses on selecting the appropriate PPE based on the specific risks. This includes understanding the various types of PPE from gloves and respirators to gowns and eye protection. Training should emphasize the proper procedures for donning, doffing, maintaining, and disposing of PPE to ensure its effectiveness in protecting researchers from exposure. The use of respiratory protection requires additional screening and training.  
• Emergency Procedures: Preparedness and response to emergencies like spills and exposures must be covered.
  • Emergency preparedness and response training must cover procedures to handle spills and exposures, an exposure control plan (i.e., bloodborne pathogens training), accessing emergency contact information, and how to report an incident involving biohazards.

How to Monitor Biosafety Performance

Monitoring biosafety performance is an ongoing process that should be integrated with the continual improvement of an organization’s EHS management system. Automating performance monitoring ensures the effectiveness of training and adherence to safety protocols. This typically involves regular inspections, incident reporting, data analysis and trending, and program evaluation to identify areas for improvement. The formation of a biosafety committee would also improve performance monitoring.

Biosafety training plays a role in protecting lab personnel and can safeguard the broader community from potential outbreaks and environmental contamination. Training should be periodically evaluated to ensure its addressing the risks in your organization and establishing an adequate level of competence.

Electronic lab notebooks (ELNs) benefit both industrial and academic labs. The ability to quickly query all your laboratory activities to identify new avenues for discovery or to troubleshoot an ongoing issue is a massive advantage over traditional paper notebooks. 

However, setting up and maintaining an ELN so that all the benefits of going digital are available is not trivial. 

This is where an ELN consultant (such as Rebecca De Souza) can help set you and your lab up for success! In the blog below, we'll discuss what an ELN consultant is and the top 6 ways I've seen ELN consultants help laboratory teams achieve digitalization zen.

What is an ELN Consultant?

An ELN consultant is a laboratory professional who provides guidance and expertise in choosing, implementing, customizing, and optimizing an ELN for a laboratory. ELN consultants are crucial in helping research organizations effectively leverage digital tools, enhance collaboration, and ensure compliance with industry standards and regulations.

6 Ways an ELN Consultant Can Benefit Your Lab

#1: Take the setup burden off of your laboratory staff

Selecting and setting up an ELN often falls on the shoulders of laboratory personnel, who must balance ELN implementation with their usual lab responsibilities. This makes sense, given that they will be the primary users of an ELN. 

However, it does take away valuable time spent conducting research or other laboratory tasks. In addition, given the newness of ELNs, many lab workers don't have experience using an ELN, much less know the best path to selecting and setting one up. 

An ELN consultant works with lab professionals tasked with ELN selection and setup, providing valuable knowledge through experience. They can help your team establish your lab's needs, show how different ELNs compare when meeting these needs, create a plan for ELN rollout, identify common setup pitfalls and how to avoid them and assist with the training staff. While laboratory staff involvement is a critical component of ELN setup success, having an ELN consultant to help ensures that the laboratory team can focus more on their everyday responsibilities while still staying involved in the ELN selection and implementation process.

#2: Navigate the needs of stakeholders

Three primary stakeholders are invested in the success of an ELN:

1. The corporation or principal investigator (PI) / lab head
2. Legal and IP teams
3. Laboratory staff

Each of these entities has a vested interest in ensuring that lab data is recorded, searchable, and auditable. 

However, each party's expectations may differ or be in direct conflict. For example, the corporation or PI and legal and IP stakeholders may expect overly detailed ELN record keeping but not consider the time investment or practicality of keeping records up to date. Discordance between these three groups can result in low ELN compliance and confusion about the expectations or purpose of the ELN, which can ultimately lead to the abandonment of an ELN. 

Having navigated this trifecta of needs before, an ELN consultant can help those tasked with selecting and setting up an ELN. The consultant can directly interface with all three stakeholders or assist those in charge of the ELN implementation and maintenance with these interactions. Keeping this trifecta of stakeholders in balance will ultimately lead to the long-term success of your lab's ELN.

#3: ELN organization

While the name ELN suggests that it is a simple replacement for a traditional paper notebook, it's more akin to a filing cabinet than a notebook. As this analogy suggests, an ELN (depending on which one you're using) is more like an organizational system allowing data input and storage. 

Most ELNs have a built-in organizational structure. For example, the eLabNext Digital Lab Platform has the Project>Study>Experiment structure, with additional options to create project groups as an extra layer of organization. 

It can be tempting to allow each individual or team in your lab to determine how to use the built-in organizational tools; however, this can lead to confusion when searching for specific data. How a corporation or lab decides how to structure its ELN organization will depend on their individual needs, and an ELN consultant can use their experience to help guide that decision and harmonize the organization structure across team members. If you already have an ELN and need to restructure and re-organize, an ELN consultant can also help with this!

#4: Generating workarounds and increased efficiency

If carefully selected, the ELN you choose should be capable of fulfilling most of your lab's needs — emphasis on the "most," as there are often lab-specific scenarios that no software developer could preconceive. ELN consultants can help devise workarounds to cover these unforeseen situations, whether they are suggesting alternative approaches or working with a software developer on your behalf to create a solution. They can also assist by using their experiences working in a lab with an ELN to assess the impact of required ELN tasks on day-to-day laboratory workflows and where streamlining can be applied to increase efficiency.

#5: Better training and documentation

After selecting an ELN, deciding on its organizational structure, and setting it up, it must be rolled out to the larger team or organization. This involves creating an ELN handbook or usage policies and providing training. 

An ELN consultant can assist by directly creating these documents and training sessions/videos. They can also work with your designated laboratory, "Super Users," to help train current and new staff or with additional training when new ELN features become available. This can reduce your staff's training burden so they can focus on their other research-focused objectives.

#6: ELN compliance

An ELN is only as useful as the data recorded in it. As such, ELN compliance is vital for success. Many of the topics discussed above can impact ELN compliance, and an ELN consultant can assist with avoiding common compliance pitfalls. 

Suppose your organization or lab has known non-compliance issues or needs help identifying compliance issues. An ELN consultant can assist you with assessing the current degree of compliance, identifying barriers to compliance, and creating strategies for increasing compliance.

Experience the Benefits of an ELN Consultant

An ELN consultant can provide valuable assistance as your organization or lab navigates the ELN landscape. They can reduce the burden of setting up and maintaining an ELN, allowing your team to return to what matters most: their next discovery! 

If you need an ELN consultant, contact me at rebecca.a.g.desouza@gmail.com or connect with me on LinkedIn.

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Materials that are hazardous due to their biological or infectious properties are called biohazardous materials or simply biohazards. Research laboratories work with a variety of biological agents including recombinant or synthetically derived nucleic acid, blood, tissues, body fluids, cell lines, bacteria, viruses, viral vectors, plasmids, fungi, prions, or parasites that cause disease in humans, animals, or plants.

To ensure the safety of people, the environment, and the public, it’s crucial to have proper biosafety measures in place. Certain workplace safety laws require employers that are exposed to transmissible infectious pathogens to have effective written safety plans and controls in place. Employers must conduct biosafety risk assessments to determine which employees have exposures from work activities or conditions that are reasonably anticipated to elevate risk of contracting a disease caused by an infectious agent.

Laboratories that perform procedures with biohazardous materials that contain transmissible pathogens are likely to have occupational exposure to these agents. A biosafety risk assessment evaluates risks, so the appropriate control measures are implemented to prevent illness.

What is a Biosafety Risk Assessment?

A biosafety risk assessment is a systematic process that identifies, evaluates, and mitigates risks associated with the use of biological agents. It aims to:

• Identify procedural hazards and hazardous characteristics of biological agents that are handled.
• Classify biological agents into risk groups according to their degree of risk of infectivity, virulence, pathogenicity, availability of preventive measures and effective treatments, and potential damage to the environment.
• Determine the appropriate biosafety level for controls and restriction understanding.
• Consider biosecurity which focuses on the prevention of theft, loss, and misuse of hazardous biological agents and toxins, equipment, and/or valuable information.
• Identify and implement controls to minimize the risk of exposure to biological agents for workers, the environment, and the community.
• Ensure regulatory compliance with local and national biosafety regulations.

Other factors to consider in a biosafety risk assessment are the possible routes of transmission of infection in the laboratory, the infectious dose, stability in the environment, host range, whether the agent is indigenous or exotic to the local environment, and the genetic characteristics of the agent. If biological agents are genetically modified, ensure that the risk assessment considers how the agent’s hazard characteristics may change, including its infection potential and severity of disease.

Key Components of a Biosafety Assessment

A comprehensive biosafety risk assessment typically involves five key components:

1. Hazard Identification: This step involves identifying all the biological agents involved in laboratory activities and the potential hazards associated with the biological agents. Use subject matter experts that are familiar with the hazards to assist with this step.
2. Hazard Assessment and Risk Evaluation: After identifying the hazards (i.e., biological agents), determine the risks of these agents by evaluating the likelihood of exposure, and the severity of exposure with the following criteria:
   • Routes of transmission – Understanding a biological agent's natural transmission route helps identify potential risks within a laboratory setting. However, the route of infection and resulting disease can differ in laboratory-acquired infections due to the higher concentrations of agents used in the lab and the potential for aerosolization during procedures, even if the agent isn't naturally transmissible by air.
   • Host range –The variety of different species that a biological agent can infect and potentially cause disease in.
   • Virulence – The severity of disease that a biological agent can cause in a susceptible host. It essentially reflects the degree of harm the agent can inflict on an infected individual.
   • Infectivity – Ability of a biological agent to establish an infection in a susceptible host.
   • Pathogenicity – Inherent ability of a biological agent to cause disease in a susceptible host.
   • Allergenicity – Potential of a biological agent to induce an allergic reaction in a susceptible individual.
   • Stability – Ability of a biological agent to maintain its physical, chemical, and biological properties over time and under different conditions.
3. Risk Management: Based on the hazard assessment and risk evaluation, appropriate measures are put in place to minimize or eliminate identified risks. This may involve elimination or substitution of hazards, the implementation of engineering controls, establishment of safe work practices and training, and usage of personal protective equipment.
4. Documentation and Communication: Document the risk assessments and findings. All relevant employees and stakeholders should be informed about the risk assessment findings, corrective and preventive actions (CAPAs) to mitigate risks, and CAPA schedule.
5. Review and Update: Biosafety risk assessments should be reviewed periodically and when hazards or operations change.

Biological Risk Groups and Biosafety Levels

Biological agents are classified according to their risk level when considering infectivity, pathogenicity and availability of preventive measures and treatments for the corresponding disease. The National Institute of Health has established classification of biological agents into four risk groups:

• Risk Group 1 – Agents that are not associated with disease in healthy humans.
• Risk Group 2 – Agents that are associated with human disease which is rarely serious or for which preventative or therapeutic interventions are often available.
• Risk Group 3 – Agents that are associated with serious or lethal human disease for which preventative or therapeutic interventions may be available (high individual risk but low community risk)
• Risk Group 4 - Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk).

The risk groups are not equivalent to the biosafety levels (BSL). The BSL assigned to a laboratory is determined by the risk posed by the biological agents being used. Each BSL has specific EHS requirements for laboratory practices and techniques, equipment and containment measures, and facilities design. The BSLs are:

• BSL-1:
  • Suitable for work involving well-characterized agents not known to cause disease consistently in immunocompetent adult humans.
  • Agents present minimal potential hazards to personnel and the environment.
  • Basic practices such as hand washing, the use of personal protective equipment like lab coats and gloves, and good laboratory hygiene are typically sufficient.
• BSL-2:
  • Builds upon BSL-1 requirements.
  • Suitable for work involving agents that post moderate hazards to personnel and the environment.
  • Additional precautions beyond BSL-1 include controlled access to the laboratory, specific training for personnel, and the use of appropriate personal protective equipment.
• BSL-3:
  • Builds upon BSL-2 requirements.
  • Applicable to facilities where work is performed with indigenous or exotic agents that may cause serious or potentially lethal disease through the inhalation route of exposure.
  • In addition to BSL-2 controls, BSL-3 facilities have additional engineering controls such as specialized ventilation systems to prevent the release of infectious aerosols.
• BSL-4:
  • Builds upon BSL-3 requirements.
  • Required for work with dangerous and exotic agents that pose a high individual risk of aerosol-transmitted infections and life-threatening disease that are frequently fatal and for which there are no vaccines or treatments.
  • Required for related agents with unknown risk or route of transmission.
  • Most stringent safety and containment measures including complete isolation from the outside environment through multiple airlocks and highly specialized ventilation systems.

How Chemical Safety Improves Biosafety

If your biosafety program is recognized as a weakness and your organization is stronger in chemical safety, harness your strengths and leverage those best good practices to apply to your biosafety program. Maintaining a comprehensive chemical safety program is helpful for biosafety because it supports organizations to:

• Comply with regulations – As an example, many regulatory agencies require laboratories to maintain accurate chemical inventories as part of compliance with EHS regulations. Having a well-documented inventory aligns with regulatory, emergency preparedness, and auditing requirements. Laboratories should use a similar system for controlling the inventory of infectious agents.
• Identify hazards and perform risk assessments – A chemical safety program helps identify and assess the potential hazards associated with the chemicals used in the laboratory. This includes factors like flammability, toxicity, corrosivity, and reactivity. This type of evaluation is important because it highlights taking a risk factor-based approach to manage laboratory hazards, which can be translated over when performing biosafety risk assessments.
• Emphasizes safe work practices – Hazardous waste can be chemical or biological. Proper procedures to classify, segregate, and dispose of chemical waste aligns with procedures to reduce contamination to the environment or exposure to personnel, which is similar to biosafety. There are safe handling practices for different classes of chemicals, including proper personal protective equipment usage, labeling, and storage procedures. This ensures that chemicals are handled and stored in a way that minimizes the risk of spills or other incidents. Similar practices and procedures should be developed for biosafety.

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• Integrate training and awareness – Biological and chemical agents are frequently handled together (e.g., research processes, decontamination procedures). An integrated approach ensures that both biosafety and chemical safety principles are covered in training programs for laboratory personnel. This training equips personnel with the knowledge and skills to handle both biological agents and chemicals safely, minimizing the risk of accidents or exposures.

How SciShield Can Standardize Your BioSafety

With SciShield, you can scale your biosafety management to improve safety, reduce time to approval, eliminate error, streamline communications, and meet compliance regulations.

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Barcoding biological samples and integrating this information with laboratory sample management software offers a more efficient means for tracking a wide range of biospecimens. The blog below discusses sample barcoding and its advantages over traditional sample tracking methods.

What is Sample Barcoding?

Biological sample barcoding assigns a unique identifier to an individual biospecimen, analogous to barcodes used on consumer products. Barcodes provide a reliable means of cataloging and tracking the location and application of samples used in a laboratory, particularly when integrated with sample management software. 

Before Barcoding: Relying on Manual Methods for Sample Management

Before barcoding was applied in laboratories, researchers employed various traditional methods to track biological samples, often relying on manual and time-consuming processes. One method still used by many labs is documentation in a lab notebook, where detailed records, handwritten notes, and labels are meticulously maintained. This method, however, is prone to human error and could lead to misinterpretation or loss of crucial information. Even when spreadsheets are used to manage and track sample inventories, there is still room for human error and mistakes. 

Physical tagging systems, such as numbered or color-coded labels, are often implemented to distinguish samples. While these methods are better than relying solely on written records, they still have limitations, especially when dealing with large-scale studies or when long-term storage is required. The absence of a standardized and universally applicable system makes data sharing and collaboration challenging. 

The Benefits of Barcoding

Sample barcoding helps provide solutions for these challenges. While not all scientists transitioned from paper records or disjointed software solutions, there are some key reasons for the growing interest in sample barcoding and its integration with comprehensive lab information software.

Sample Identification and Tracking

Barcoding provides a unique identifier for each biological sample, reducing the chances of errors in sample identification. Integration with laboratory sample management software enables real-time tracking of sample locations, movements, and usage history. This metadata provides a more comprehensive view of a sample collection compared to manual sample management methods.

Efficient Data Management

Combining barcodes with sample management software allows for efficient and accurate data entry. Researchers can quickly scan barcodes instead of manually entering sample information, reducing the risk of transcription errors. It streamlines data management by providing a centralized platform for storing and retrieving sample-related information.

Automation and High Throughput

Barcoding facilitates automation in sample-handling processes. Automated systems can scan and process samples more quickly and accurately than manual methods. This is particularly important in high-throughput laboratories where large numbers of samples need to be processed efficiently.

Sample Integrity and Reproducibility

Barcoding helps maintain the integrity of samples by reducing the likelihood of mix-ups or contamination. By integrating with sample management software, researchers can ensure the reproducibility of experiments by accurately documenting and tracking sample conditions and parameters.

Compliance and Quality Control

Barcoding and software integration help laboratories adhere to regulatory and quality control standards. They also enhance traceability and auditability, which is crucial for compliance with various industry and research regulations.

Time and Cost Savings

Streamlining sample management processes through barcoding and software integration can save time and reduce operational costs. Automation and efficient data handling contribute to overall workflow optimization, allowing researchers to focus more on the scientific aspects of their work.

Data Integration and Analysis

Integration with sample management software enables seamless integration with other laboratory systems, facilitating comprehensive data analysis. Researchers can correlate sample information with experimental results, helping them draw meaningful conclusions from their data.

Collaboration and Data Sharing

Barcoding and sample management software facilitate collaboration by providing a standardized and easily shareable format for sample information. Researchers from different labs or institutions can more effectively share data, fostering collaborative efforts and accelerating scientific progress.

Conclusion

Combining barcoding and laboratory sample management software improves the efficiency, accuracy, and overall management of biological samples in research lab settings. 

If you’re considering the eLabNext platform or are a current eLabNext customer who hasn’t taken advantage of sample barcoding yet, explore the Biobanking section of the Marketplace or check the ZPL Printer add-on or FLUICS PRINT add-on. eLabNext can also provide a list of printers and scanners supporting sample barcoding. If you are a ZPL, Brady, or FLUICS customer looking to make your next steps on your digital journey and want to be the with the ‘Easiest to Use’ and ‘Best Value’ ELN provider, then request a demo or jump straight to your free 30-day trial of eLabNext.

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The National Institutes of Health (NIH) has recently implemented new data management and sharing (DMS) requirements for grant applicants and recipients. For all researchers seeking or currently funded by NIH grants, a data management and sharing plan must be submitted detailing how they will make their data available to other scientists and the public. 

Ultimately, this change benefits science, scientists, and society as a whole: “Sharing scientific data accelerates biomedical research discovery, in part, by enabling validation of research results, providing accessibility to high-value datasets, and promoting data reuse for future research studies,” states the NIH on its website. 

However, realising these benefits and implementing a DMS plan may take a lot of work. Some labs lack the infrastructure and data recording practices for effective data management and sharing. To rectify this problem, labs will have to rid themselves of outdated lab recordkeeping practices – such as paper lab notebooks and rudimentary databases that act as black holes (data goes in, never to be seen again) – which are no longer viable solutions. 

Therefore, winning an NIH grant is now tied to modern digital laboratory platforms, which are more effective data management and sharing tools. Labs lagging on digitisation are facing new financial motivations to implement changes. 

Meeting New DMS Requirements with eLabJournal

To facilitate data sharing through digitalisation, researchers can use eLabJournal, a secure, user-friendly, cloud-based lab notebook and data management platform. eLabJournal makes it easy for researchers to enter, store, and share their data with other scientists and the public while ensuring that sensitive information is protected and data privacy laws are complied with.

Here are a few ways researchers can benefit from using eLabJournal and comply with the NIH’s new DMS requirements.

Store data in a secure and accessible manner

eLabJournal has access control options to ensure that only authorised users can view or modify their data. The platform is built on a Roles & Permissions authentication model to ensure data security within the organisation. Customisable password policies, two-factor authentication, IP range restrictions, and VPN tunnelling all support data security from external threats. All of this is obtained through a web browser interface, meaning the security you put in place will not stand in the way of you accessing your data from wherever you happen to be working that day.

Share data with other scientists and the public

The eLabJournal platform has a customisable data-sharing plan that can be included in a grant application. Through the intuitive interface, users can generate simple, customised exports of sample or experimental records. eLabJournal’s open development architecture supports even more powerful data sharing and manipulation through our extensive library of API calls. 

Ensure compliance with data privacy laws

eLabJournal uses industry-standard security protocols to protect sensitive information, including 21 CFR part 11, GDPR, GxP, and HIPAA compliance. 

Integrate DMS plans into your digital lab platform

eLabJournal can incorporate many add-ons in the eLabMarketplace, enabling customisation and expanded functionality. One of eLabJournal’s add-ons, DMPTool, presents plan summaries within eLabNext, along with a link to download complete plans. This tool enables researchers to maintain compliance and manage DMS plans from the grant drafting process through the post-award period.

Digitalisation, at no extra cost

The new NIH requirements mean you can build the cost of eLabJournal into your grant itself. The NIH has clarified its instructions: Costs associated with a data management plan, including software subscription fees, may be included in the budget for the related project. 

Data Sharing Requirements and Digitalisation go Hand-in-Hand

In conclusion, the new data-sharing requirements for NIH grants represent a significant change in how research is conducted and how data is shared. Using eLabJournal, researchers can easily meet these requirements, promote collaboration, increase transparency, and improve public access to research data. Furthermore, many old excuses preventing labs from enacting data management modernisation are now moot: If you are applying for NIH funding, digitalisation is necessary.

If you want to see how eLabJournal can help your lab effectively manage and share data, schedule a free demo today!

Lab asset inventory audits are critical for maintaining an organized, efficient, and compliant laboratory environment. A comprehensive lab asset inventory audit can support environment, health and safety (EHS) controls, limit costs, and improve operations. Lab assets encompass everything from equipment, and chemicals, to software and furniture. In this article we highlight the importance and benefits of conducting these audits from an EHS perspective focusing on equipment and chemicals.

The Importance of Asset Management in Labs

Effective asset management in laboratories involves a systematic approach to procurement, maintenance, upgrades, and disposal of assets.

Effective asset management can improve:

• Procurement of proper equipment that mitigates risks with engineering controls and that is sustainably designed.
• Maintenance schedules of equipment and potentially reduce malfunctions, injuries, and accidental releases.
• Optimization of chemical inventories by minimizing hazardous materials storage, and ultimately risks of exposure.
• Regulatory compliance against preventative maintenance and monitoring requirements.
• Waste mitigation efforts by extending equipment lifespans and minimizing resource consumption.

1. Defining the Scope and Preparing Resources

The first step of the inventory audit is defining the scope. Identify which facilities, equipment, chemicals, and other assets will be included in the audit. Identify any applicable compliance obligations for the audit (e.g., Occupational Safety and Health Administration Nationally Recognized Testing Laboratory [OSHA NRTL] Program).

Assemble your team for the inventory audit. Gather resources by preparing checklists, barcode scanners (when applicable), and labels for tagging assets. Prepare the lab inventory management software (if available).

2. Performing the Initial Inventory Audit

• Start with tangible equipment such as lab equipment. Record the
  • Location
  • Condition
  • Make and model
  • Relevant dates (e.g., acquisition)
  • Brief description of the asset
• When possible, group similar assets together to simplify identification.
• After entering this data into your database, tag the equipment with concise labels with essential information such as name, ID number, date of acquisition, and safety information. Consider a color-coding system when labeling to distinguish ownership, health and safety classification, lab zones/work areas, etc.
• Assign specific locations for each category of assets to avoid clutter and facilitate retrieval, where applicable. Ensure storage areas are accessible and appropriate for the specific items (e.g., temperature-controlled for certain chemicals).
• Inventory all chemicals by the following classifying information but not limited to:
  • Estimated volumes
  • Storage locations
  • Expiration dates
  • Supplier/manufacturer information.
• Use all available resources such as colleagues to help inventory, bar coding system, and chemical inventory management software, if available.

3. Evaluating Results

Identify the gaps, missing items, outdated equipment, duplicate chemicals, etc. This may take a long period of time to understand trends but it’s important to analyze the asset usage patterns and compare them with the inventory.

Assess the condition and performance of the equipment. Flag any equipment that requires maintenance, repair, upgrade, or needs to be safely decommissioned and disposed of. It may be an inventory but you’re also visually inspecting for any noticeable damage or defects.

For chemicals, evaluate the usage data and expiration dates across several inventory audits to avoid unnecessary hazardous chemical storage and disposal, which could have environmental impacts.

4. How to Automate Best Practices, Corrective and Preventive Actions (CAPAs)

Assigning Team Responsibilities

• Determine roles and responsibilities for inventory audit tasks and ensure your team is trained on the system.
• Build and foster a culture of shared responsibility for inventory management. Increased ownership/engagement, visibility, and communication of the inventory activities brings forth proactive solutions, promotes efficiency and optimizes processes.

Organization and Storage

• Implement a first-in, first-out system to avoid expiring chemicals persisting in storage areas.
• Regularly dispose of obsolete or damaged items. Don't let outdated equipment or expired chemicals occupy valuable space and pose health and safety risks. Establish clear disposal protocols for different asset types.
• Store equipment based on frequency of use. Keep frequently used equipment within reach while infrequently used items be stored on higher shelves or in designated areas.
• Streamline asset identification and data entry with barcode scanners.

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Procurement and Cost Management

• Forecast future asset needs and use bulk purchases when possible, to take advantage of any discounts.
• Seek help from your procurement department (if applicable) and compare prices across different suppliers to find what works best for you from an EHS perspective but also operationally and financially.

Maintenance and Calibration of Equipment

• Implement routine maintenance schedules for equipment to ensure optimal performance and prevent unexpected breakdowns.
• Document equipment usage and calibration records. Maintain accurate records of usage logs and calibration certificates for compliance.

Automate Recordkeeping and Documentation

• Recordkeeping and documentation are prone to error due to their history of being maintained with only Excel spreadsheets and physical notebooks. Lab inventory management software to ensure accurate documentation and uniformity with your data.
• Set clear expectations for your team on recordkeeping.

• Move from Excel spreadsheets and physical notebooks to lab inventory management software to automate your documentation and ensure accuracy.
• Develop templates or forms to ensure consistency in data collection.
• Ensure that records are complete when conducting the inventory audit, so you don’t have to double your effort.

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Conducting Routine Inventory Audits

• Communicate the importance of routine audits to your team and lab personnel. Routine audits ensure you meet compliance obligations for asset management, chemical storage, and equipment safety. Failure to comply could result in serious penalties, injuries, and fatalities.
• Implement a regular schedule for inventory audits (e.g., monthly, quarterly, annually).
• Update records with current information with each subsequent inventory audit.

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5. Specific Considerations for Lab Relocation

Lab relocations can be complicated, especially when it comes to asset inventories. Some tips for navigating a lab relocation are:

• Conduct a comprehensive inventory of all assets, prioritizing the criticality of the assets (e.g., EHS critical equipment, frequently used assets, and assets with special transportation or storage requirements).
• Identify the chemicals and equipment that need to be either disposed of properly or decommissioned first to avoid unnecessary transport risks.
• Use appropriate storage containers to protect equipment and prevent exposure to chemicals.
• Ensure that chemicals and chemical storage containers/boxes are labeled appropriately according to regulatory requirements.
• Maintain a record or chain of custody of asset movement to avoid loss or damage.
• Implement safe work practices including proper waste disposal procedures for the new lab.
• Schedule calibration for equipment upon arrival. Perform a Pre-Startup Safety Review (PSSR), as needed, to check for potential hazards prior to using the equipment.

Conclusion

In conclusion, lab asset management isn't centered around just operational efficiency and cost cutting; it also involves proactive EHS monitoring and measurement. By conducting routine inventory audits, you are fostering a culture of continual improvement that values the protection of personnel, the environment, and your company’s reputation.

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Scientific research is rapidly evolving. The traditional approaches to documenting seed and plant storage face inherent challenges that hinder efficiency and progress. This has sparked a transformative shift towards digital technologies that address these challenges and provide solutions.

Opting for an electronic storage system represents a strategic decision to streamline operations while enhancing the accuracy, accessibility, and longevity of valuable genetic resources.

In this blog, we'll delve into the impact of electronic technology, such as specimen management inventories, in revolutionising the entire process of managing critical data.

Meticulous Documentation is the Key to Success

Before transitioning into the digital realm, it's crucial to recognise the paramount importance of appropriate sample storage and management.

• Seeds and plants represent the foundation of agricultural and ecological studies, acting as reservoirs of genetic diversity.
• A precise record-keeping system ensures the preservation of this diversity for ground-breaking research, innovative breeding programs, and impactful conservation initiatives.

Essential Features of A Digital Seed and Plant Storage System

Exploring how a virtual documentation platform can revolutionise the research experience:

Electronic Databases: Your Gateway to Intelligent Sample Management

• An online inventory provides a seamlessly organised system on a centralised platform.
• Researchers can experience efficient input, management, and retrieval of specimen data. Everything from species characteristics to geographic origins and genetic information.
• Examples like GRIN and Genesys showcase the power of electronic databases in transforming the storage and accessibility of crucial data.

Barcode Technology: Precision In Every Scan

• Say goodbye to the tedious process of data entry and minimise the risk of manual errors with an efficient barcoding system.
• Every specimen is assigned a unique identity. This ensures quick and accurate identification, tracking, and management.

Climate-Controlled Storage with Sensor Integration: Preserving Nature’s Blueprint

• An electronic platform safeguards each specimen with climate-controlled conditions to ensure an optimal storage environment for seed integrity and viability.
• Real-time monitoring and integrated sensors provide an alert mechanism to promptly detect any deviations.

Mobile Applications: Empowering Researchers On The Go

• Transform your field research experience with cutting-edge mobile applications for on-the-go data capture.
• Information such as storage location, images, and associated notes can be recorded in the app and seamlessly synchronised with a centralised database.

Advantages of Digital Documentation

Efficiency and Time Savings

• An online system transforms time-consuming tasks such as manual record-keeping and data entry into an automated process.
• Researchers can focus on analysis and experimentation, which significantly boosts overall productivity.

Data Accuracy and Integrity

• Eliminate the risk of illegible handwriting and transcription errors with a paperless solution.
• A digital platform ensures the data linked to every plant and seed is accurate and reliable, which ensures the integrity of research outcomes.

Global Collaboration

• Overcome geographical barriers with the power of a system platform, enabling researchers to collaborate globally with ease.
• If appropriate, access to a centralised database could facilitate information exchange, fostering shared germplasm contribution to the global genetic resource pool.

Adaptability to Changing Technologies

• In the fast-paced world of scientific research, a digital documentation system can be easily updated and integrated with the latest tools and applications.
• This adaptability ensures that seed and plant storage practices remain at the forefront of scientific advancements.

Conclusion

The digital management of seed and plant storage represents a paradigm shift in scientific research practices. By embracing technological solutions, researchers and scientists can enhance work productivity and contribute to the global effort of preserving biodiversity and advancing agricultural and ecological knowledge.

As we continue to navigate the complexities of our ever-changing world, the virtual landscape offers a promising path for the sustainable management of genetic resources.

Elevate your research potential with an advanced electronic sample management platform. Embark on a new era of efficiency in the digital world today.

Lab safety inspections are crucial for a variety of reasons, but their ultimate purpose is to protect the well-being of everyone in the lab and the environment. Here are the primary reasons why lab safety inspections are conducted:

• Prevent Accidents and Injuries: Labs are filled with potentially hazardous materials and equipment. Inspections identify and address health and safety hazards to prevent accidents, protecting lab personnel and visitors from injuries like burns, explosions, and exposure to harmful substances.
• Ensure Regulatory Compliance: Labs are subject to various regulations regarding safety procedures, waste disposal, and environmental protection. Inspections ensure that labs comply with these regulations and help avoid fines and legal consequences.
• Promote Safe Work Practices: Inspections assess if proper safety work practices are being followed, like wearing personal protective equipment (PPE), handling/storing of chemicals, and disposing of hazardous waste. An evaluation of internal adherence with these work practices promotes a culture of safety within the lab and encourages everyone to prioritize working safely.
• Identify Improvement Opportunities: Inspections can reveal areas where procedures can be improved, controls can be upgraded, or training can be enhanced. This continuous improvement leads to a safer lab environment for everyone.

Conducting the Lab Inspection

• Define the Scope and Prepare Resources

The first step of the lab inspection is defining the scope. Identify which buildings and labs will be included in the inspection. Gather as much information as you can, such as:

• • The type of activities taking place in the lab
  • An overview of the hazardous materials and equipment
  • Lab safety manual, SOPs, and emergency procedures
  • Previous inspection reports, including outstanding issues

Are there specific programs or safe work practices that you’ll be evaluating or is this a general lab inspection? Familiarize yourself with the regulations and standards that apply to your lab from agencies such as the Occupational Safety and Health Administration (OSHA) or National Fire Protection Association (NFPA). Assemble your team and prepare checklists for the inspection (e.g., lab inspection software on tablets, hard copy documents, etc.).

• Schedule the Inspection

Contact the lab manager(s) to schedule a convenient time for the inspection. Note that some inspections may need to be unannounced so you’re able to observe how the lab normally operates without any audit preparation.

Outline the areas you’ll visit in the lab and the order you’ll visit them in. Allocate sufficient time for each area based on its complexity and potential hazards.

• Review of Lab Safe Work Practices and Programs

There are several programs you may need to include in your lab inspection. Below are some examples of guidelines or requirements that you’ll want to consider including in your inspection checklist.

General Safety Best Practices

Below are some general safety guidelines to keep in mind during a lab safety inspection:

• Follow general housekeeping and cleanliness guidelines. Look for clutter, spills, and improper storage of chemicals or equipment.
• Wear appropriate personal protective equipment (PPE) as required by the lab, including lab coats, safety glasses, and gloves.
• Always wear appropriate clothing when working in a lab. Protect your skin, avoid open-toed shoes and long/dangling jewelry, and keep sleeves at an appropriate length.
• Be familiar with the emergency procedures and the locations of emergency equipment, such as fire extinguishers, fire blankets, safety showers, and eye wash stations.
• Use appropriately designated waste containers to dispose of liquid and solid waste.
• Report any accidents or injuries to supervisors immediately.

Chemical Safety Best Practices

Chemicals are some of the most dangerous hazards in a lab. Here are some of the requirements to look out for regarding chemical safety.

• Eyewash stations should be readily accessible in case of chemical splashes. Ideally, they should be located within a 10-second walking distance from any potential chemical splash hazard. Obstructions should be cleared from the path to the eyewash station and in the immediate surrounding area.
• Chemical labels should clearly identify the chemical name, hazards (including pictograms) in accordance with the Globally Harmonized System (GHS) of Classification and Labeling of Chemicals, CAS number, concentration, and any special handling instructions.
• Flammable liquids, acids, and bases are to be stored in approved storage cabinets and cabinets, ensuring incompatible chemicals are not stored together.
• Requirements for maximum allowable quantities (MAQs) of chemical storage.
• Chemical fume hoods should be used appropriately and tested/certified.

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Hazardous Waste Safety Best Practices

Adequate handling, storage, and disposal of hazardous waste protects workers from exposure, reducing the risk of occupational illnesses and injuries. Proper hazardous waste management also ensures local ecosystems and communities are shielded from the negative environmental consequences of hazardous waste disposal. Below are some key areas to inspect:

• Hazardous waste storage area (i.e., Satellite Accumulation Area and Main Accumulation Area) requirements ensure compliance with specific regulations governing the storage of hazardous waste on-site.
• Properly maintained containers help prevent leaks and spills that could lead to environmental contamination and health & safety hazards. Clear labeling ensures that hazardous waste containers are properly identified, which facilitates tracking, inventory management, and regulatory compliance. Container condition and compatibility with the waste are also important in prevention of incidents.

}

Biological Safety Best Practices

There are many measures to maintain a safe laboratory environment with biological hazards, protecting employees from potentially harmful biological agents and preventing the spread of contamination. Here are a few:

• Similar to chemicals, use appropriate containers like vials, biohazard bags, and secure freezers for different types of materials and ensure clear labeling with agent information, storage temperature, date of collection, etc.
• Clear and visible biohazard signs serve as visual reminders of potential risks and encourage safe practices. They should be placed at the entrance of the lab, on biohazard waste containers, and near areas where biological agents are handled.
• Wear appropriate PPE. Lab coats/gowns act as a physical barrier, protecting from splashes, aerosols, and contact with potentially infectious materials. They should be worn whenever handling biological agents, even for short procedures.
• Ensure access to appropriate disinfectants for quickly and effectively decontaminating surfaces and equipment after use. Prompt and thorough disinfection prevents the spread of contamination within the lab and protects employees from exposure.
• Biological safety cabinets (BSCs) provide a controlled environment for handling highly infectious or volatile agents. The cabinet's airflow and filtration systems protect users from airborne contaminants. Regular certification by qualified professionals ensures the BSC is functioning properly and meeting safety standards. A compromised BSC can increase the risk of exposure. }

Radiation Safety Best Practices

Understanding and implementing proper measures is crucial to protect employees and the environment from the potential harm radiation exposure can cause. Here are some critical areas to inspect:

• Clear and visible radiation warnings and easily recognizable symbols like "Caution: Radioactive Materials" must be displayed on storage containers, equipment, and areas where radioactive materials are present.
• Regularly calibrated Geiger-Müller counters (GM meters) allow for precise measurement of radiation levels in the air and on surfaces.
• Designated, secured storage areas with controlled access minimizes the risk of unauthorized access or accidental exposure.
• Clear and detailed labels including materials, activity level, potential hazards, etc. provide important information for safe handling and use.
• Permits and licenses for radioactive materials should be current and include the radioactive material type, quantities, and intended use.

Additional Considerations

Laboratory inspections can include a wide range of Environment, Health and Safety (EHS) programs in the scope, or they can be more focused. Ensure you know what’s included in the scope of your inspection so you can be as efficient as possible. Some other considerations when conducting an inspection are:

• Review the safety training records and ensure all personnel have received mandatory training.
• Check for proper documentation of chemical inventories, incident reports, and previous safety inspections.
• Verify that any corrective and preventive actions (CAPAs) following previous inspections have been implemented effectively.
• Offer constructive feedback and suggestions for improvement in a positive and collaborative manner.
• Recognize and praise good safety practices observed during the inspection to encourage a culture of safety in the lab.}

Resources

Resources you’ll want to keep handy are lab inspection templates such as the Lab Audit Checklist, a list of applicable regulations, and other EHS resources from government agency or laboratory organization websites such as:

• Occupational Safety and Health Administration (OSHA): https://www.osha.gov/
• Environmental Protection Agency (EPA): https://www.epa.gov/
• National Fire Protection Association (NFPA): https://www.nfpa.org/en
• American Chemical Society (ACS): https://www.acs.org/
• American Biological Safety Association (ABSA): https://absa.org/
• Association for Laboratory Accreditation (A2LA): https://a2la.org/

In June 2013, a Canadian medical lab, Lifelabs, lost patient files and personal information of more than 16,000 patients. A computer sent for servicing was returned without its hard drive, containing valuable ECG results gathered at three local facilities between 2007 and 2013. Its lab data management failed due to its enormous cost.

More recently, in April 2023, a ransomware attack at a medical testing lab, Enzo Clinical Labs, based in New York, caused a serious data breach, exposing more than 2.5 million customers. Personal data, medical files and lab results were compromised.

Theft and destruction: Today, holding critical data on hard drives is risk-prone and not considered best practice. They’re a single point of failure, and this centralised storage is vulnerable to destruction, theft and corrupt data. While no system is impervious to being attacked, measures around the privacy of your customers, lab research and confidential information must be taken seriously.

The Investigator pointed out that “healthcare providers are prime targets for ransomware attackers. They sometimes have less robust IT systems and have a high incentive to pay the ransom to regain control of systems and protect patient data.”

Old data: Another serious issue is data loss due to the unsuccessful transfer of physical medical files and data to electronic versions. Today, data is lost at a rate of 17% annually, and 80% of datasets older than 20 years are no longer available.

• How robust are the privacy measures around your lab’s research data?

• Are you confident that your files are secure?

• Are your old and historical data archived properly?

Find out how eLabNext can provide a solution for your lab requirements.

In this blog, you will find:

1. What is Lab Data Management (LDM)?
2. What digital platforms does your lab need?
3. What happens when your LDM fails?
4. What are the priorities of lab data management?
5. A checklist of a proper lab data management system
6. How did you rate?
7. An elegant, all-in-one lab data management solution

Let's begin!

What is Lab Data Management?

Lab Data Management (LDM) is the systematic organisation, storage, retrieval and analysis of data generated in a laboratory environment. This encompasses samples, inventory, experiments, findings, instruments, photos and more. It is crucial and central to many industries and disciplines, including biology, chemistry, physics and environmental sciences. 

The primary goal of lab data management is to ensure that data is: 

• Accurately recorded
• Securely stored
• Easily accessible for analysis and reporting

It’s imperative to assess the scalability and flexibility of the system to accommodate future growth and changes in research teams. Beyond that, its users are human beings with a mix of IT savviness, so user-friendly interfaces and ease of integration with existing laboratory instruments and systems are pivotal in decreasing human input error and accidental data removal.

A good LDM system will factor in the following:

• The size of the laboratory
• The complexity of experiments
• Data security requirements
• Regulatory compliance needs
• Budget constraints

A successfully implemented LDM mitigates theft, loss of data and human error.

What digital platform does your lab need?

It’s important to understand the differences in labels and offerings out there so that your lab has the best digital platform for its needs, objectives and flow. Broadly speaking, there are LIS platforms and ELN platforms.

LIS has increasingly (and confusingly) come to mean a few different things: Lab Information Systems and Lab Inventory Systems. 

ELN is an electronic lab notebook platform. It is meant to replace physical notebooks found in labs. 

Very few LIS or ELN platforms today offer a complete lab solutions platform for inventory, protocol and journaling that all labs need. Most are complicated, require third-party software that forces disparate software to work as one and are not as versatile with cross platforms.

Do you know which platform is best suited to your needs? Why?

Make sure you check out our next blog, where we deep dive into these different platforms and compare elements to aid you in ensuring the platform you use for your lab is best suited to your needs.

Information integrity today: when a LDM fails

Today, information is money. Medical facilities and research labs come under attack because of the rich content of personal information, including addresses, passwords, contact details, health vulnerabilities, patent information, corporate secrets and research findings. They are targeted in various ways, including:

• Ransomware Attacks Cybercriminals may deploy ransomware to maliciously encrypt critical medical and research data, demanding a ransom for its release. 
• Data Breaches Attackers may aim to steal sensitive patient information, research data, or intellectual property. Stolen healthcare records can be valuable on the dark web for identity theft, insurance fraud or other malicious activities.
• Phishing Attacks Phishing emails, which attempt to trick individuals into divulging sensitive information, are a prevalent threat. In healthcare and research settings, attackers may use fake emails to access login credentials, financial information or sensitive research data.
• Supply Chain Attacks Cybercriminals may target the supply chain of medical facilities or research labs. Compromising the security of vendors, suppliers, or partners can provide attackers with a pathway to infiltrate the primary target.
• Advanced Persistent Threats (APTs): APTs involve highly sophisticated, targeted attacks often carried out by well-funded and organised groups. These attacks aim to gain persistent access to networks, often for espionage purposes and can be particularly challenging to detect.
• Disruption of Healthcare Services Cyberattacks may be aimed at disrupting critical healthcare services, such as patient care systems, medical devices or communication infrastructure. This has severe consequences for patient safety and overall healthcare operations.
• Intellectual Property Theft Research labs are often targeted for intellectual property theft, including valuable scientific discoveries, experimental data or proprietary information.
• Internet of Things (IoT) Vulnerabilities Many medical devices and laboratory equipment leverage the Internet of Things If IoT devices are not properly secured and managed. Security vulnerabilities in these devices can be exploited to gain unauthorised access, disrupt operations, or steal sensitive information if IoT devices are not properly secured and managed.

In May 2019, an American Medical Collection Agency (AMCA) data breach impacted the privacy of more than 22 million patients. It costs €361,000 to involve IT professionals and consultants from three different firms to identify the source of the breach, diagnose its cause and implement appropriate solutions. Furthermore, 

more than €3.5 million was spent meeting legal requirements and regulatory obligations. AMCA was forced to reduce its workforce from 113 to 25 employees to cope with its sudden financial repercussions.

• How savvy is your lab data management system?

The priorities of Lab Data Management

Where do issues arise when choosing an LDM? What do you need to consider before making the choice? Does your LDM provider cover the following?

Data Quality Assurance

Data Quality Assurance in Lab Data Management refers to the systematic process of ensuring the accuracy, completeness and reliability of laboratory data. It involves validating data at various stages, implementing quality control measures and adhering to standardised protocols. This ensures that research findings and clinical results derived from the data are trustworthy and meet regulatory requirements. 

If this is compromised or fails, it can lead to inaccurate research outcomes, compromised patient care decisions, and regulatory non-compliance. Inaccurate data may result in flawed analyses, misinterpretations, and erroneous conclusions, impacting the integrity of scientific research or diagnostic procedures. 

What is lost if your lab’s data quality assurance is weak? It’s the trust your customers place in laboratory results that can hinder further collaboration. It poses serious ethical and legal consequences in the fields of healthcare and scientific research.

Have you heard of Samplecheck5000? It may sound particularly attractive to labs, but it is actually malware developed to specifically target labs for its sensitive data!

Data security and confidentiality

The data your lab collects is confidential for your customers and your proprietary research and findings. Protecting your data’s confidentiality and security involves implementing measures to safeguard sensitive information generated or stored in laboratories. This includes protecting patient records, research findings and proprietary data from unauthorised access, disclosure or alteration. Security measures may include encryption (in transit and at rest), access controls and secure storage protocols.

Inadequate measures to protect your data can destroy the integrity of your business and cause massive financial debts to fix and compensate for damages. In today's IoT era, it is easy to gain unauthorised access to sensitive patient information, intellectual property theft or regulatory violations. Patient privacy may be jeopardised, leading to legal consequences and damaging an institution's reputation. Research findings may be at risk of theft or manipulation, impacting the validity and trustworthiness of scientific outcomes. 

ISO 27001 The ISO 27001 is an international standard published jointly by the International Organization for Standardization and the International Electrotechnical Commission in 2005. It provides benchmarks for managing information security, and the latest standards were updated in 2022. When an organisation is aligned and certified by ISO 27001, it becomes a tool for risk management, cyber-resilience and operational excellence.

• Is your LDM ISO 27001 certified?

Data storage and retrieval

Data storage and retrieval in Lab Data Management refer to the systematic organisation, storage and efficient retrieval of laboratory data. Today, scalable solutions are vital to cope with the evolving growth of samples or customers needed. Hard drives or even servers have limited capacity for storage—Cloud-based solutions offer flexibility and are engineered to remove single points of failure. 

It is imperative that your lab data management involves establishing secure and accessible repositories for diverse types of data, such as experimental results, patient records and research findings. Effective storage systems ensure data integrity, accessibility and long-term preservation. 

If compromised, data storage and retrieval issues can lead to data loss, corruption or delays in accessing critical information. Lab researchers can run into issues hindering scientific progress and decision-making. In a healthcare setting, patient care is impacted when there are delays in accessing vital medical records—or even worse, when data is lost. 

Old and historical data, particularly within a medical environment, is still relevant when treating a patient—if those files and folders succumb to fire, flooding, accidental destruction or chemical damage, the valuable information is irretrievably lost. Not to mention printing inks that might fade over time or suffer insect attacks, such as silverfish. Proper archiving is essential to prevent further loss.

Data integration

Data comes from all sources, particularly if we include historical and archived data—which can be important to derive valuable patterns and trends for lab and research use.

Data integration in Lab Data Management involves consolidating diverse data sets from different sources within a laboratory or across multiple laboratories. It aims to provide a unified and coherent view of data, facilitating comprehensive analyses and informed decision-making. Effective data integration enhances collaboration, accelerates research and enables a holistic understanding of complex scientific phenomena. 

If compromised, incomplete or inaccurate datasets can hinder researchers' ability to derive meaningful insights. Inconsistencies in integrated data may lead to erroneous conclusions and impact the reliability of research outcomes. Additionally, failed data integration can impede interdisciplinary collaborations, slow down research progress and introduce inefficiencies in laboratory workflows. 

Data governance

Data governance in Lab Data Management refers to the establishment and enforcement of policies, procedures and standards to ensure the quality, integrity and security of laboratory data throughout its lifecycle. It involves defining roles, responsibilities, and guidelines for data management, access, and usage. 

Effective data governance promotes accountability of data streams, data consistency, transparency and compliance with regulatory requirements. 

Data governance issues can lead to data inconsistencies, unauthorised access and regulatory non-compliance. Lack of clear policies and oversight may result in data mismanagement, compromising the reliability and trustworthiness of research outcomes. 

Data backups

Backups are essential in the lab environment. It involves creating duplicate copies of critical data to safeguard against loss or corruption. This process ensures the availability of data in the event of accidental deletion, hardware failure or other unforeseen issues—and can help protect against ransomware. Regular backups contribute to data resilience and are crucial for maintaining the integrity of research findings and patient records. 

Cloud-based Lab Data Management (LDM) solutions offer benefits such as automated backups, scalability, and accessibility. With cloud-based LDM, data is stored off-site, reducing the risk of data loss due to on-site disasters. A good SAAS-delivered LDM platform will ensure your data should be encrypted in transit and at rest.

The consequences of not backing up data or not being rigorous in choices, levels of security and frequency can be severe. Loss of critical data may impede ongoing research, disrupt laboratory workflows and compromise the continuity of patient care. Without reliable backups, recovery from data loss becomes challenging, potentially resulting in permanent loss of valuable information, setbacks in research projects and compromised scientific integrity. 

Data traceability

Increasingly, data provenance is highly sought—as it allows the data to be traced to its source, its human owner and inputter and creates accountability and integrity.

The ability to track and document the origin, processing steps and modifications of laboratory data throughout its lifecycle is essential to publishing research, accessing research grants and moving the needle forward to creating a successful solution/product. It involves maintaining a comprehensive audit trail that ensures transparency, accountability and compliance with regulatory standards. 

With data traceability, researchers can validate and reproduce results, verify the quality of data, and adhere to stringent documentation requirements. Cloud-based LDM solutions enhance data traceability by providing de-centralised storage, automated version control and access logs. This facilitates collaboration, reduces the risk of errors and ensures that data can be reliably traced back to its source.

Compliance

Maintaining compliance in a lab environment, particularly in environments governed by Good Laboratory Practice (GLP) guidelines, is critical. The GLP is a set of principles and standards established 

by various national and international regulatory agencies. One of the key organisations involved in developing and promoting GLP principles at the global level is the Organisation for Economic Co-operation and Development (OECD). In the European Union, GLP regulations are outlined in Directive 2004/10/EC, which was later incorporated into the Good Laboratory Practice Regulation (EU) No 2017/160.

The primary objective of GLP is to facilitate the generation of high-quality and credible data, particularly in industries such as pharmaceuticals, chemicals and biotechnology. Regulatory bodies rely on the data generated in non-clinical studies to make decisions about the safety and efficacy of products before they reach the market. Adherence to GLP helps ensure that the data produced is of the highest quality, minimising the risk of errors, fraud and misinterpretation.

Compliance encompasses data collection, storage, retrieval, and documentation processes to meet regulatory requirements and maintain the quality of research outcomes.

A cloud-based LDM system provides several benefits, such as de-centralised and secure storage, automated audit trails, and version control mechanisms that facilitate traceability, allowing organisations to demonstrate compliance during regulatory inspections within their supply chain. Cloud-based solutions also enable scalability, accommodating the growing volume of data generated in research labs and ensuring efficient and cost-effective management.

The consequences of non-compliance can be severe, especially when failing to meet GLP guidelines. Regulatory penalties, data rejection by authorities and damage to the institution's reputation are potential outcomes. 

🡪 What can happen at a legal level if your lab is not digitised? Read our whitepaper. 

Version control

Systematic management and tracking of changes made to datasets, software and analysis tools over time ensures version control for a successful Lab Data Management (LDM). With effective version control, researchers can identify, compare and revert to previous versions of data or software, maintaining data integrity and reproducibility. 

Failure to have effective version control results in challenging management of multiple versions of datasets. The reliability and efficacy of data sets weaken, leading to confusion, errors and difficulties in reproducing or validating research results. 

Data ownership and intellectual property

Data ownership and intellectual property (IP) involve defining and protecting the rights and responsibilities associated with generated data and intellectual contributions. In the context of a research lab, IP encompasses the creations, innovations and discoveries conducted within the laboratory. It often includes:

• Patents
• Copyrights (software code, scientific publications)
• Trademarks (lab names, logos or brand names)
• Trade secrets like methods, techniques or procedures, recipes (e.g., in perfumery, food & drink production)
• Databases/sets
• Innovations (e.g., if a lab or organisation designs their own novel equipment or devices.)

Researchers, institutions and collaborators need clear agreements on data ownership, authorship and intellectual property rights to avoid disputes and ensure ethical use. De-centralised LDM systems can facilitate these aspects by providing transparent access controls, audit trails and collaborative platforms. Permissions can be fine-tuned, ensuring that only authorised individuals can access, modify or share specific datasets, safeguarding sensitive information and adhering to legal and ethical standards.

This is an extremely important facet of your Lab Data Management. If this is compromised, costly disputes may arise over authorship, data usage or intellectual property rights.  Inadequate protection may discourage innovation, collaboration and the secure exchange of data, hindering scientific progress. 

Training and documentation

At the end of the day, any Lab Data Management system is only as good as the ability of the user to comply. It is no good if the user insists on sticking with notebooks, pens and pencils! Training and education on proper data management practices and maintaining comprehensive records outlining data handling procedures are vital for lab users. While the software may be intuitive, it still needs humans to be properly initiated into its usage.

Training ensures that individuals understand the importance of data integrity, security and compliance with relevant regulations. Clear documentation provides guidelines and standard operating procedures (SOPs) for data collection, storage, analysis and sharing.

Documentation is also crucial: Cloud platforms facilitate real-time updates, ensuring all users can access the latest information. Training modules can be delivered remotely, fostering efficient onboarding and continuous education for lab personnel.

Data reporting

Efficient data reporting is crucial for communication, decision-making and meeting regulatory requirements. 

Data reporting is the systematic and accurate presentation of research findings, experimental results and analytical outcomes. This process includes creating comprehensive reports, summarising key insights and ensuring that the data presented is clear, transparent and adheres to relevant standards. Cloud-based solutions enhance data traceability, ensuring that the reported information can be linked back to its source and supporting reproducibility.

Without high-level data reporting, the dissemination of inaccurate or incomplete information results in flawed interpretations hinders collaboration and impacts the credibility of research outcomes. Inadequate reporting practices can also lead to regulatory non-compliance, especially in industries where adherence to standards is essential. 

Electronic Lab Notebooks (ELN) integration

Electronic Lab Notebooks (ELN) are digital versions of traditional paper lab notebooks. They enable researchers to record, organise and share experimental data electronically, improving collaboration, data accessibility and traceability in laboratory settings. There are many ELN software in the market but few integrate seamlessly with inventory systems, LIMS and LIS software too—particularly one within its own ecosystems.

Does your Electronic Lab Notebooks (ELN) integrate seamlessly with the other systems in your Lab Data Management (LDM) or is it disparate and glitchy? The benefits of ELN integration include being able to access their electronic notebooks securely from anywhere, facilitating remote collaboration; while real-time synchronisation ensures that the latest data entries are instantly available to the entire team. 

Data silos are a very real problem when integration fails, causing data to be scattered across various platforms, hindering collaboration and traceability. Incomplete integration may result in data duplication or loss, affecting the accuracy and completeness of experimental records. Security vulnerabilities in the ELN integration can expose sensitive information to unauthorised access, risking data integrity and confidentiality.

Resource constraints

Every lab has to work within set budgets, personnel and IT support. Integrating considerations regarding implementing and maintaining advanced data management systems into decision-making within a laboratory setting is vital. Laboratories often face challenges in allocating funds and dedicated personnel for robust data management infrastructure.

Select Cloud-based LDM solutions that eliminate the need for extensive in-house IT infrastructure, reducing upfront costs and providing scalable and secure solutions. Cloud-based LDM also allows labs to benefit from regular updates and improvements without the need for costly in-house IT support.

Without adequate financial investment, labs might resort to suboptimal data management practices, potentially leading to data loss, inconsistency and reduced data quality. 

Collaboration

By definition, research within the lab environment often sits in collaboration with teams, not only within the physical confines of the lab but with partners and other teams around the world. The science world is a highly social world, with the need to collaborate with other teams in moving the process forward for their innovation, be it chemical, medical or aeronautical.

Is your Lab Data Management system able to work with other platforms seamlessly? Does it recognise other platforms?

Collaboration in Lab Data Management (LDM) involves the seamless sharing, integration and coordination of research data among team members—in- and out-of-house—and across different projects. Effective collaboration is essential for enhancing research outcomes, accelerating discoveries and fostering interdisciplinary cooperation within laboratories.

Cloud-based LDM systems allow researchers to work on the same datasets in real-time, irrespective of geographical location. These platforms also support standardised collaboration tools, ensuring uniformity in data management practices and enhancing interoperability.

Inconsistencies lead to errors, misinterpretations and delays in research projects. Inventory can be mixed up, ELN entries can be confusing, leading to data silos, hindering efficient information exchange and collaborative decision-making. Progress of research is impeded, which undermines the quality of scientific outcomes.

A checklist of a proper Lab Data Management system

Is your Lab Data Management system up to scratch? Will it pass muster today? Does it include the following?

• Data quality assurance.

• ISO27001 level security for my data so that confidentiality is maintained.

• Data is stored following modern best practices so that theft, destruction, misplaced hard drives, and computers can easily be avoided.

• My data storage flexes and scales with the needs of my team and research.

• I can easily and reliably access and retrieve my data, no matter how old it is.

• My LDM facilitates easy data integration with multiple platforms and diverse data sets.

• My data is governed by the proper establishment and enforcement of policies, procedures and standards to abide by regulatory requirements.

• My LDM ensures proper backups to secure ISO 27001-certified solutions.

• I have the ability to track and document the origin, processing steps and modifications of my laboratory data throughout its lifecycle.

• My LDM provides a high level of GLP-compliant checks to ensure my data is credible so that I can rest easy, knowing that my innovation/product is both safe and efficacious.

• My LDM systematically manages and tracks changes made to datasets, allowing me to identify, compare and revert to previous versions of data if I need to.

• My LDM provides transparent access controls, audit trails and collaborative platforms, negating issues of data ownership and compromised intellectual property.

• My LDM provider ensures that my team and I are adequately trained to use the software and have proper documentation to refer to for help.

• My LDM generates reporting for systematic and accurate presentation of research findings, experimental results and analytical outcomes.

• My LDM seamlessly integrates my ELN with our inventory systems, LIMS and LIS software.

• My LDM comfortably fits within our lab’s allotted budgets, personnel and IT support.

• My LDM allows me to collaborate with my team effortlessly—and even others within the ecosystem of my study.

How did you rate?

Data is increasingly valuable—which also means it is increasingly vulnerable. Labs spend tens of thousands to ensure the integrity, security, integration and strength of their lab data management. And yet, many don’t work seamlessly and are stapled together piecemeal, often using a workaround.

🡪 What other lab data management considerations are there? Read our other whitepapers.

A simple solution

eLabNext’s Lab Data Management is simple. We don’t like complicated. Our ecosystem of software comes in three separate modules, but all designed to work as one. What’s more, our entire ecosystem is certified ISO27001, not just the separate modules.

eLabJournal is our all-in-one electronic lab notebook (ELN). It has been designed to work seamlessly with our eLabInventory and eLabProtocol modules, providing the complete software solution for labs all over the world. We offer secure hosting plans as well as our expertise across Cloud-based hosting solutions, such as AWS, which is often considered the gold standard.

🡪Have a read about our take on what to consider when choosing the right ELN for your lab.

To securely manage your data, a decentralised, Cloud-based solution is ideal. It offers the following four main benefits:

Scalability

Because Cloud-based data solutions do not rely on you having a physical disk under your desk or in a cabinet in your building, it can expand and contract with your user pool and needs. It is also able to maintain acceptable performance as demand increases. The Cloud has "infinite" scalability as long as the applications and systems are architected optimally.

eLabNext is a Software as a Service (SaaS) solution—this means scalability is built into its strength and flexibility.

🡪 Read how easy it is to digitise your sample collection, organisation, labelling and more.

Security

Under the hood, Cloud-based data storage is designed to be decentralised, with encrypted parts of the data separated across physical disks and physical cabinets in a data centre, ideally across geographical locations. This allows the data to remain whole even if one physical cabinet fails—the Cloud can intelligently fill in the gaps. 

eLabNext allows you to control and govern your applications and data through user authentication and authorisation. We have systems in place to prevent and detect security events; our Cloud-based solution is more secure because you have a greater ability to manage security settings, which include greater logging and monitoring and the ability to take automatic actions. 

Reliability

Labs need their data and databases to be reliably delivered at any moment. Unreliable systems can mean the loss of important research results and data. Cloud-based lab data management reduces anxiety because it is a system that can serve traffic with minimal/no downtime. Additionally, the Cloud can be more secure because everything is engineered for high availability—after all, it has no single point of failure.

Equally important is eLabNext’s software ecosystem, which allows reliable integration between eLabJournal, eLabInventory, and eLabProtocol. This means no integration issues can disrupt the reliable storage, saving and cataloguing of lab data.

Resiliency

Decentralised storage systems better withstand failures and disruption by design. It can continue to serve traffic while maintaining integrity of security because redundancies are built in. Recovery can also be automated to self-heal.

eLabNext’s ISO 27001 certification includes our expertise in creating environments for your data that protect your valuable findings, patient/sample info, publications and ability to move your product to market.

ISO 27001 The ISO 27001 is an international standard published jointly by the International Organisation for Standardization and the International Electrotechnical Commission in 2005. It provides benchmarks for managing information security; the latest standards were updated in 2022. When an organisation is aligned and certified by ISO 27001, it becomes a tool for risk management, cyber-resilience and operational excellence.

Find out more

Do you want to know more about a lab data management system that ticks all the boxes in our checklist? Our team members are experts in tech and software and have backgrounds in science and lab environments. Speak to an insider about selecting the best lab data management system that is designed from the core for your needs.

We also welcome you to sign up for a trial.

Who is eLabNext?

Please peruse our easy-to-navigate website to find out more about eLabNext. It is our mission to elevate life science research with tools that are elegantly designed from the code-up. Our eLabNext platform is powerful enough to fit the needs of 10 or 5,000 lab research teams—but remains pared down in bulk and unnecessary elements that make software bloat and become clunky over time.

We’re a Dutch-born-and-based software endeavour founded by research scientists in 2010. Erwin Seinen and Wouter de Jong developed eLabNext because they were frustrated with their paper notebooks and how software systems out there were not seamless and did not integrate with each other, including equipment, security, inventory, and sample tools. 

Today, we have offices in the Netherlands, UK, USA and Australia, servicing labs all over the world. We help future-proof their digital platforms so that they can keep doing what they do to help better the human experience and our planet.

Congratulations, you’ve adopted an Electronic Lab Notebook (ELN) and taken a significant step forward in streamlining your laboratory research! With your data organised and accessible in a digital format, you’re on your way to more efficient and collaborative scientific endeavours. However, having an ELN is just the beginning.

Previously, we’ve discussed the step-by-step process of implementing an ELN in a new or existing lab. In this blog, we’ll explore what comes next and how to make the most of this powerful digital tool.

Master the Basics

Before diving into the more advanced features, take the time to familiarise yourself with the basic functionalities of your ELN. Learn how to create and edit entries, organise folders, and attach files and images. Becoming proficient in these fundamental operations will lay a strong foundation for your ELN journey.

Explore Collaboration Tools

ELNs are designed to foster collaboration among researchers. Explore the collaboration features of your ELN, such as shared notebooks, comments, and version history. Collaborators can provide valuable feedback, contribute to experiments, or even take over when you’re away, ensuring continuity in your research.

Take Advantage of Integrations and Add-Ons

Taking advantage of ELN integrations and developed add-ons opens up a world of possibilities for researchers. Integrations with data analysis tools streamline data processing and enable real-time visualisation, empowering researchers to draw meaningful conclusions from their experiments. Additionally, utilising add-ons developed by the ELN provider can extend the platform’s capabilities, providing customised solutions for specific research needs, such as equipment scheduling, electronic signatures for compliance, or sample tracking tools. Embracing these integrations and add-ons maximises the potential of your ELN, making research more efficient, collaborative, and productive.

Set Up Custom Templates

Standardise, standardise, standardise! Tailor your ELN to suit your specific research needs by creating custom templates. Templates can simplify data entry and ensure consistent and standardised formatting across experiments. Consider templates for experimental protocols, project overviews, or data analysis sheets. Investing time in creating templates will save you time in the long run.

Stay Organised

With the ability to generate a vast amount of digital data, staying organised is crucial. Create a clear and intuitive folder structure for your experiments and data. Use tags and metadata to label and categorise entries efficiently. A well-organised ELN will make data retrieval and analysis a breeze.

Backup Regularly

Data is the lifeblood of scientific research, and losing it could be devastating. Always have a robust backup system for your ELN data to “future-proof” your research. Cloud-based solutions or server backups can protect your research from accidental deletions or hardware failures. Most cloud-based ELNs have reliable backup redundancy strategies to ensure your data is safe and secure.

Secure Your Data

As with any digital platform, data security is of utmost importance. Protect your ELN with strong passwords and multi-factor authentication. Ensure your ELN platform complies with relevant data protection regulations to safeguard sensitive research information.

Regularly Review and Revise

Periodically review your ELN entries and make necessary revisions. Keeping your ELN up-to-date and error-free will enhance the reliability of your research and prevent potential issues down the line.

Conclusion

As you navigate this new digital terrain, remember to master the basics, customise your ELN to suit your needs, embrace collaboration, stay organised, and prioritise data security. With the right approach, your ELN will become an invaluable companion in your scientific journey, accelerating your research and promoting collaboration within your team. Happy experimenting!

If you need resources to help you navigate these next steps, contact us today!