In my previous post, I described the challenges of certification, accreditation, and federal approvals, and how software can have a huge impact on the speed and ease with which your team goes through the process. For forward-thinking laboratory and technical leaders, however, regulatory approvals can also offer an opportunity to make software improvements that will help your business respond to evolving requirements and market forces with more agility and confidence.

Working With a Partner Can Simplify and Accelerate the Process

For labs undergoing accreditations, a partner can provide knowledge around software processes and practices that can greatly help a lab present a “complete” system. Labs that have not previously gone through accreditation can benefit from having a partner that has a history of working with industry regulatory processes, as well as experience in the foundational practices of software development.

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Most mature labs already understand the process of certification and accreditation. They also tend to recognize where they’ve hit roadblocks in the past. For these labs, a partner with the right industry and regulatory experience and services can help them address specific concerns.

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For labs working toward FDA approvals, one of the biggest challenges we see is a hesitation to embrace functional changes to their software systems. Often the gap between understanding how software development can help a lab and “total automation of a lab” is quite large, leading to resistance during implementation. However, a partner’s focus on process and structure can resonate with lab staff and bridge the gap between software and lab processing in a way that reduces potential friction between in-house teams.

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Labs undertaking FDA approvals for the first time can also benefit from a partner with the capacity to implement, document, and test systems in conjunction with lab processes. Integrating software into lab processes, rather than having them independent from each other, can lead to increased efficiency, improved productivity, and reduced costs.

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Labs more experienced with the FDA process can take advantage of the specific skill sets offered by some partners. They might need assistance at a strategic level or a partner with a strong technical understanding of their system and the ability to document it at that same technical level. Or they might need development services. Wherever they are on the journey, experienced labs tend to understand when additional consultation can augment, rather than replace, their own internal work.

Key Questions to Ask

If your lab is pursuing certification or accreditation or undergoing FDA approvals, I recommend considering whether you have the software and team in place to support the process. Ask yourself the following:

• Is your software system modern and modular? Working towards systems with comprehensive testing coverage, preferably automated, is a primary goal of many labs looking to pursue accreditations or approvals.
• How mature are your software system and the software team in your lab? If your system lacks maturity or your team doesn’t have experience with regulatory approvals or software design and architecture, working with a partner could help make the process smoother.
• Does your software system support traceability? FDA approvals go beyond the typical software standard of how a solution is built. The FDA wants to know “why” and “how”, but it also wants to see supporting evidence and traceability.
• Can your software system meet FDA requirements? These are often stricter than software industry standards and/or the standards used by many software teams. See my previous post for examples.
• Does your lab have the necessary internal teams in place to manage FDA and regulatory program initiatives, audits, and documentation? It’s important to have a champion in the organization who can ensure your team has the resources you need. The approval process doesn’t stop with successful submission. Systems must be maintained, updated, documented, and re-tested to ensure functionality and reliability are meeting expectations.

It takes effort to gain certification, accreditation, and/or approvals. Working with the right partner to strengthen your software infrastructure and build in automation can help you address regulatory program requirements with minimal overhead. We have a thorough knowledge of industry regulations and experience working through the process with other clinical labs. Whether or not your lab is new to the process, let us help you make it as painless as possible.

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