How To Pass Your Next FDA Audit

FDA Audit Readiness Software

For asset managers, the FDA and Form 483 can often seem like the boogeyman — just more real and with considerably higher consequences. Enduring and passing FDA audits are a regular part of your job, but they never get easier or less nerve-wracking.

Every organization has its own specific compliance needs, but there are a few ways to ensure you pass every audit with ease, no matter your industry. To help prepare your organization, team, and assets, use these tips to pass your next FDA audit.

Prepare, prepare, prepare

You never know when your next audit is scheduled, so operate as if the FDA will be knocking on your door at any minute. While you might receive advance warning as a courtesy from the FDA, you are just as likely to be audited when you least expect it. To best prepare for your next audit, make these tasks a priority:

  • Create a plan – When an FDA inspector walks in, your organization should be able to calmly and instantly respond. Each member of your team should know their role and be able to fulfill it without a problem. You don’t want chaos and panic to leave a bad impression on your auditor, so use your plan to ensure a smooth process.
  • Know what to expect – Use the FDA guidelines to understand what is expected. Then, even if your audit has unexpected demands, you’ll be better prepared to meet every need. With this official knowledge, you can get everything ready for use at any time.
  • Ensure your system’s readiness – Your asset management system will play a vital role in your FDA audit, so keep it up-to-date and ready-to-go at all times. Most importantly, make sure your team knows how to access the information you need through it before the inspector arrives.

With preparation, you can plan for anything you might experience during your audit and set your organization up for success.

Ready your documents

You should have all of the necessary documentation available and accessible at all times. Your documentation is proof of your compliance, so you should have records of every operation and process. During your audit, you must be able to quickly retrieve any documents requested by the auditor. The more organized you are, the faster the process will go and the better you can impress your inspector.

Utilize internal audits

Practice makes perfect, especially when dealing with something as involved and important as an FDA audit. Conducting internal audits throughout the year may be tiresome and stressful, but they are required for full compliance and are the best way to prepare. For total readiness, follow the same process as an FDA audit, but be even more thorough. Use the opportunity to train your staff and fix any issues before they become violations. When you can easily pass your own internal inspection, you will be in good shape for the next official audit.

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