Regulatory Compliance in the Lab

With 8+ years of experience in the lab, EHS, and regulatory compliance, with organizations such as Lubrizol and Sherwin-Williams Mary Lucas is a great asset to the Albert team and brings a wealth of knowledge to both Albert and to our customers.
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Helping Albert’s customers with regulatory automation is a key component to their success in accelerating innovation and time-to-market. Though in order to do this effectively, it’s important to understand the nuances and importance of regulations and their impact in the lab.

That’s why we’re delighted to have subject matter experts on our team, like Mary Lucas. In her role as Regulatory Technical Specialist, she supports the ongoing value we continue to add to Albert’s end-to-end R&D platform and guides our customers on platform onboarding, training, and success.

In this Q&A Mary shares her insights and thoughts on regulatory compliance and challenges in managing it, along with how Albert helps.

Q: Why is Regulatory Compliance in the lab so important?

To understand the importance of regulatory compliance, it is important to remember first and foremost, regulations establish a culture of safety and exist to protect workers.

No one wants to fall out of compliance, because it brings risk to those working, using and transporting chemicals and hazardous materials. Compliance infractions, beyond safety concerns, be they with Occupational Safety and Health Administration (OSHA), Department of Transportation (DOT) or other regulatory groups and standards, can also shut down laboratories for periods of time and even impact the ongoing existence of the organization. So, it’s a pretty big deal!

Q: What are the main Regulatory Standards that R&D labs have to adhere to?

There are numerous regulatory standards that R&D labs have to adhere to. The differences will depend largely on their industry, products, intended use, where they operate and many more.

In the US, the most common regulatory standards include Environmental Protection Agency (EPA) regulations. These are standards that regulate the storage, use, and disposal of hazardous waste products, including those produced by R&D labs. Another is Occupational Safety and Health Administration (OSHA) Regulations: These regulations cover the management of chemical hazards, as well as other workplace safety issues.

Organizations that operate across borders will have their own regional-specific standards to comply with. Some examples include Europe’s alignment with the European Commission’s REACH (registration, evaluation, authorization, and restriction of chemicals) and the European Union’s CLP Legislation through the European Chemicals Agency. Korea has Korean REACH (K-REACH) through the Ministry of Environment. The list goes on with different countries around the world.

The list and requirements for R&D labs can be robust, but it’s always important to remember regulations are there for a reason.

Q: What are some of the biggest challenges of managing regulatory standards and compliance?

Several barriers come to mind. The regulatory landscape is complex (per above) and continues to change. In such a dynamic regulatory environment, with different rules depending on your scenario or location, and new revisions and updates being released constantly, it makes it tough for organizations to keep up and ensure compliance.

Organizations often have health, safety and regulatory professionals who are well versed. However, they’re not always the people in the labs doing hands-on experiments. This can lead to a disconnect from a safety perspective, which bleeds into another issue – the challenge of having access to reliable, up-to-date data.

As a result, trying to find regulatory data is often time consuming and hard to identify a single source of truth that everyone in the lab can trust and rely upon.

This leads to an even bigger challenge when it comes to managing regulatory standards and compliance; generating accurate and up-to-date labels and Safety Data Sheets (SDS) that are both required and needed to ensure safe usage of materials. SDS and labels are usually authored by a department outside of the lab or by 3^rd party consultants or vendors. The disconnect between the lab and these parties can delay product shipments by days to weeks; delays can potentially derail a project and frustrate customers.

Finally, scientists don’t have access to the regulatory data at their fingertips, which can lead to off-spec products which might be designed for a customer in China, when one of the chemical substances used isn’t even registered on the Inventory of Existing Chemical Substance in China (IECSC)!

Q: Lots of challenges in managing regulatory compliance. Though the good news is, Albert can help, please share!

Simply put, Albert makes managing regulatory compliance easy. Our team has a deep background in chemistry and material science, so we understand lab challenges at a personal level and help address lab barriers head-on.

The Albert solution includes a comprehensive database of industry standards and raw materials (50,000+) that we continuously update. This empowers scientists to have access to critical and up-to-date information, even before they order the chemical from the vendor. We also enable our customers to generate compliant shipping labels and SDS in one-click vs waiting for days or weeks for someone else to do it manually.

These capabilities are a HUGE advantage to our customers. We often hear from our customers about how thankful they are for these components of our solution, as it saves quite a bit of time and frustration. No longer are they chasing down the right data or waiting for support from outside the lab!

Worth noting, Albert’s single source of truth for R&D organizations also extends beyond regulatory automation, supporting smarter and faster experimentation when it comes to inventory management, designing formulations and new materials, managing experiments, and more.

Q: Is there anything else you would like to add?

Albert won’t eliminate the need for regulatory and safety professionals. Instead, it gives them bandwidth to focus on things that need their attention and provides the capabilities for our customers to innovate faster.

I tell people all the time how much I wish I’d had Albert in my previous positions. There is really nothing like our data driven insights and platform capabilities. I truly believe that Albert is changing how products are created and brought to market. I am so excited to be a part of it!