21 CFR Part 11

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What It Means

FDA 21 CFR Part 11 establishes criteria for electronic records and electronic signatures to be considered trustworthy and reliable.

Why Labs Need It

Pharma and biotech labs must demonstrate controlled electronic systems during FDA inspections.

How Ignitive LIMS Supports It

Ignitive LIMS is designed with audit trails, access control, and electronic signatures (where enabled) to support Part 11-aligned implementations when validated.

Key Features

• Audit trail on governed data
• Unique user IDs
• Electronic signature workflows
• Record retention exports

Benefits During Audit

• Faster demonstration of who changed what and when
• Reduced reliance on paper shadow systems

CTA

Primary: Book a Compliance-Focused Demo Secondary: Download 21 CFR Part 11 Readiness Checklist