21 CFR Part 11 -FDA Compliance

Egnyte satisfies the requirements of FDA 21 CFR Part 11, which defines how electronic records, e-signatures, and handwritten signatures converted to electronic records are equivalent to paper records and handwritten signatures.  To ensure that your company meets this FDA regulation, please follow the below steps.

1. Add the "Security Package"

The Security Package is included for Business and Enterprise plans. Office plans can contact their account manager to add the Security Package.

2. Create "Scheduled Audit Reports"

Configure audit reports to generate weekly. This duration is configurable but the maximum allowable time between reports is 90 days for compliance.

3. Enable "Archive Saved Audit Reports"

Navigate to Settings --> Configuration --> General --> Reporting and enable the toggle to archive all audit reports.

4. Use an e-signature vendor that complies with 21 CFR Part 11


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