21 CFR Part 11 - FDA Compliance

Overview

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 complete the following 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 the Configuration tab in Settings, open the General option, and enable the Archive saved audit reports toggle in the Reporting section.

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

 

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