5 ways to make the FDA audit process easier for your life sciences company

    Benjamin Franklin once said that two things in life are certain—death and taxes—and if you’re running a life sciences company, add going through the Food and Drug Administration audit process to that list.

    The FDA conducts audits periodically, where the auditor will look through your procedures and records and potentially collect samples. These routine audits can take longer to complete when your documents and procedures aren't properly organized (often the result of lacking audit management software). That, along with other issues, could lead the auditor to report any objectionable conditions or practices in an FDA Form 483.

    The sooner you address or fix objectionable concerns, the more favorable you’ll look in the inspector’s eyes, according to the FDA—but, again, that can be difficult if you’re not organized.

    If you want the FDA audit process to go as smoothly as possible, whether it’s an inspection or a follow-up visit, you need the proper tools and alignment within your team. These are key parts of making it easy for your inspector to quickly locate what they need, so they can complete the audit.

    RELATED READING: The audit readiness checklist

    1. Document your Standard Operating Procedures (SOPs)

    You've probably heard this phrase before: 'if it's not documented, it's not done'. This is certainly true in the eyes of the FDA, so the sooner you get your SOPs documented and implemented the better.

    Your top level SOPs should be specific, but not so detailed that you back yourself into a corner. If a process needs details, develop a lower level work instruction for use at production level, so it's easier to update and implement in case changes are needed.

    You'll also need to develop procedures, work instructions and records as required for your relevant FDA regulations. For example, medical device companies need to develop design history files that should be readily accessible internally for reference, but also externally for audits. If you have an organized, sophisticated system, you'll avoid hours of searching during audits, which will lessen the stress for everyone.

    RELATED READING: The audit readiness checklist for medical device companies

    2. Implement procedures and track employee training

    Once you document your procedures, the next step is implementing them. This involves training your staff on those procedures to ensure they understand the importance of each process and to keep them invested in your company’s goals and purpose.

    It’s also important to make sure that you can track the training. Using training management software that can manage training for you may benefit your company. Software like this can document where, when, and how employee training was completed. And more sophisticated systems can notify when training renewals are due, as established by you and your training procedure. Ultimately, your training management is something an auditor may want to see, so having easily accessible records is ideal.

    Occasionally, life sciences companies receive warning letters and need to implement corrective and preventive actions (CAPA) to fix an issue stemming from their respective requirement violations. If that issue is linked to a lack of training, then keeping your training management well documented will help the FDA auditor see how you're making progress. 

    RELATED READING: How to respond to FDA warning letters

    3. Support communication between departments

    When departments operate in silos, it can hurt your preparation for an audit. Breakdowns in communication can lead to errors, and it can be hard to reach shared goals if one department doesn’t know what the other is doing.

    One way you can try to eliminate silos within your company is by giving your team members a place to communicate about any issues or questions, whether that’s through tools like Slack or Google Docs. Encourage them to keep up continual communication and to work with each other—this could help them to unify around the company mission and quality management processes that you’ve put in place.

    When you follow this guideline, then the FDA auditor can see that teams clearly communicate with each other and have access to information needed to do their jobs correctly. For example, if someone in marketing needs access to information about the process behind creating a medical device product, then they have a platform to reach out to the correct team to get what’s needed. This can help prevent misrepresentation of your company.

    4. Conduct internal audits and consult FDA experts

    FDA audits can be daunting, but by continually conducting internal audits or mock audits, you'll make your system stronger and more resilient. Remember to empower your internal auditors to make changes and ensure they give senior management a real account of their findings. They should have full autonomy and not have any conflicts of interest with the processes they are auditing.

    Optimally, to keep things completely unbiased, you could take things a step further by hiring a third party FDA consultant to audit your entire system, or do a full on gap analysis (determine what is lacking compared to your required FDA regulations).  These auditors can detect potential deviations before an FDA inspector would and gives your entire team real-life training in what would happen during a real FDA audit. 

    Once the mock audit/gap analysis is over, you may want the consultant to stay on as an expert to guide corrections. If they're familiar with your system, they may even be able to help you during a real audit, if you feel it would be helpful.   

    RELATED READING: Tips to support remote auditing

    Get organized for an audit with quality management software

    While all of the above tips are important, another way to make the audit process easier on you (and your FDA auditor) is to store everything in one place with quality management software. There are several options available when it comes to picking an eQMS. In addition to the features mentioned above, you’ll want an eQMS that offers capabilities such as:

    • Quality Event Management — This includes ways to proactively track (and flag) potential non conformances, so you can identify opportunities for improvement (PA-Preventive Action), or find actual non-conformances that can be corrected before an audit (CA-Corrective Action).
    • Risk Management — Pinpoint risks and perform risk management to proactively find risks and adjust before an adverse event happens. This allows you to see any potential vulnerabilities along the production process and across the organization.

    Since medical devices and drug manufacturers are so heavily regulated, you may want to consider getting a quality management system that is made specifically for life sciences companies. It should offer most, if not all, of the capabilities that you’ll need to successfully navigate FDA audit inspection preparation and inspection procedures.

    RELATED READING: 9 core elements of a quality management system

    Need an eQMS purpose-built for your life sciences organization? We'd love to talk to you about Qualio