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

• Required: System description and signature use cases (what records are being signed)
• Required: Applicable regulations (21 CFR Part 11, EU Annex 11, specific GxP context)
• Required: Signature types needed (approval, review, acknowledgement, authorship)
• Optional: Current authentication infrastructure (Active Directory, LDAP, SSO)
• Optional: Existing electronic signature policy or SOPs