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.
Book a demoPart 11 governs electronic records and electronic signatures used in place of paper. An auditor reviewing it is not reading the regulation line by line. They are checking for a short list of structural controls, and this page walks through what those are.
Every GxP relevant change to a record needs a trail showing who made it, when, and what the old and new values were. The trail itself needs to be tamper evident, so a control that lets someone quietly edit history defeats the point even if a log technically exists somewhere.
A signature has to be uniquely tied to one person and cannot be reused by someone else. Most systems enforce this with password reauthentication at the moment of signing, not just a login earlier in the session. The signed record also needs to show the meaning of the signature, approval, review, or authorship, next to the name and timestamp.
Only authorized people should be able to create, modify, or delete GxP records, and that authorization should be enforced by the system, not just by a policy someone is trusted to follow. Records that have been formally approved should be locked from further edits, with any correction handled through a documented change rather than a silent overwrite.
It applies to any electronic record used in place of a paper record for a GxP purpose. A spreadsheet tracking deviations or test results usually qualifies, even though it was never designed with Part 11 controls in mind, which is exactly why spreadsheets show up so often in audit findings.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
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