Preparing for an FDA inspection, what to check first

Know your system inventory cold

Before anything else, be able to produce a current list of GxP relevant computerized systems, with a clear owner and validation status for each. An inspector asking for this list and getting a slow, uncertain answer sets a bad tone for everything that follows, even if the underlying validation work is solid.

Walk your own traceability matrices first

Pick a handful of requirements at random, the way an inspector would, and trace them yourself before the inspection happens. Fix what breaks. This single exercise, done honestly, surfaces most of the gaps an inspector would otherwise find first.

Confirm signatures and approvals are actually current

Check that approvers listed on recent records still hold the authority they had when they signed, especially after any reorganization. A signature from someone whose role changed, or who has left the company, without a documented reassignment, is a common and avoidable finding.

Rehearse how you would answer, not just what you would show

An inspector is also assessing how confidently your team can explain a process, not just whether the paperwork exists. A brief internal walkthrough of how someone would answer common questions about a given system tends to matter as much as the documentation itself.

See what a validation package looks like when it builds itself

A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.

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