Implement Electronic Signatures

Design and implement electronic signature controls that meet 21 CFR Part 11 Subpart C and EU Annex 11 requirements for regulated electronic records.

When to Use

• A computerized system requires legally binding electronic signatures for GxP records
• Replacing wet-ink signatures with electronic equivalents in a regulated workflow
• Implementing approval workflows for batch release, document approval, or data sign-off
• Regulatory gap assessment reveals missing signature controls
• Building or configuring a system that must comply with 21 CFR 11.50–11.300

Inputs