21 CFR Part 11 compliance refers to the U.S. FDA regulation that defines how electronic records and electronic signatures must be managed to ensure they are trustworthy, reliable, and equivalent to paper records. It establishes controls for data integrity, security, and auditability.
What Is 21 CFR Part 11 Compliance?
21 CFR Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA) that governs the use of electronic records and electronic signatures in regulated industries. Compliance ensures that digital systems meet strict requirements for authenticity, integrity, and traceability.
What Is 21 CFR Part 11?
21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered legally equivalent to paper records and handwritten signatures. It applies to organisations involved in FDA-regulated activities such as pharmaceuticals, biotechnology, medical devices, and clinical research.
Why 21 CFR Part 11 Compliance Is Important
- Ensures electronic records are trustworthy and reliable
- Prevents unauthorised access or data manipulation
- Supports regulatory inspections and audits
- Enables secure electronic signatures and approvals
Key Requirements of 21 CFR Part 11
- System access controls and user authentication
- Secure, computer-generated audit trails
- Electronic signature controls and verification
- Record retention and retrieval capabilities
- System validation and documentation
Who Needs to Comply with 21 CFR Part 11?
- Pharmaceutical and biotechnology companies
- Medical device manufacturers
- Clinical research organisations (CROs)
- Any organisation using electronic records for FDA-regulated processes
Manual vs Compliant Digital Systems
- Non-compliant systems: Shared drives or tools without audit trails or access controls
- 21 CFR Part 11–compliant systems: Validated platforms with security, auditability, and electronic signatures
How 21 CFR Part 11 Compliance Is Achieved
Compliance is achieved by implementing validated systems that enforce access controls, audit trails, electronic signatures, and documented procedures. Regulators expect organisations to demonstrate both technical controls and procedural governance.
Next Steps for Organisations
- Identify systems that manage FDA-regulated electronic records.
- Assess gaps against 21 CFR Part 11 requirements.
- Adopt compliant document and records management platforms.
Learn how modern document management platforms support 21 CFR Part 11 compliance by exploring document management software features, book a demo, or contact our team.
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Frequently Asked Questions
What is 21 CFR Part 11 used for?
21 CFR Part 11 is used to ensure electronic records and electronic signatures are secure, reliable, and legally equivalent to paper records.
Is 21 CFR Part 11 mandatory?
Yes. It is mandatory for organisations that create, modify, maintain, or archive electronic records for FDA-regulated activities.
Does 21 CFR Part 11 apply to document management systems?
Yes. Any document management system handling FDA-regulated records must support audit trails, access controls, and electronic signatures.
Can 21 CFR Part 11 compliance be automated?
Yes. Modern validated systems automate audit trails, security controls, and electronic signature enforcement.
