The regulation itself is not an IT standard. It does not tell you how to configure your Active Directory, how often to review privileged accounts, or what your backup retention policy should be. What it does require is that electronic records remain accurate, complete, and retrievable, and that access to them is controlled and auditable.

Those outcomes depend entirely on IT infrastructure that is properly configured and maintained. If your validated QMS software has an unimpeachable audit trail but the server it runs on has stale admin accounts and no documented patch history, you have a Part 11 problem. FDA does not grade on a curve for good intentions.

If you are doing a self-assessment before an FDA inspection, start with these three areas:

At most medical device companies under 200 employees, 21 CFR Part 11 compliance is owned by Quality. IT supports the systems but is rarely included in compliance planning conversations. That separation works fine until an inspection, at which point investigators ask IT-specific questions that Quality cannot answer and IT was never told to prepare for.

The fix is not complicated. It is a documented IT controls framework that maps to the systems supporting regulated workflows, reviewed at least annually, with evidence that can be pulled quickly when needed. NIST CSF and FDA’s own published data integrity guidance both provide practical starting points that do not require an enterprise compliance budget.

Start by listing every software system your organization uses that touches a regulated record.

If any of those answers are “I’m not sure,” that is where preparation begins. The goal is not a perfect compliance posture overnight. It is a documented, defensible position you can walk an investigator through with confidence.

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