US FDA

21 CFR Part 11 - Electronic Records and Signatures

What triggers Part 11 applicability, audit trail expectations, and how electronic signatures must be linked to records.

What this course covers

This course covers what actually triggers Part 11 applicability for a computerized system, what FDA considers a complete audit trail, how an electronic signature must be bound to the record it signs, and what validation evidence is expected to demonstrate Part 11 compliance. It is written for the people who implement and review electronic batch records, LIMS and other GMP computerized systems, not just the people who audit them afterward.

Who this course is for

IT and validation staff implementing or maintaining GMP computerized systems
QA staff reviewing electronic batch records, LIMS or other electronic GMP records
Anyone evaluating a new system for Part 11 readiness before go-live

What you'll learn

What triggers Part 11 applicability for a given computerized system
Audit trail requirements and what FDA means by a 'complete' record of changes
Electronic signature requirements and how a signature must be bound to its record
System validation expectations specific to Part 11 compliance
The most common Part 11 gaps found during FDA inspections of computerized systems

Why it matters

Part 11 gaps rarely show up as a standalone citation. They usually surface as part of a broader data integrity finding, when an audit trail cannot answer who changed a value, when, and why. Getting Part 11 right at implementation is far cheaper than remediating it after a warning letter.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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