21 CFR Part 11
Is an FDA regulation that defines when electronic records and electronic signatures are considered equivalent to paper records and handwritten signatures.
Who Must Comply
Organizations in any FDA‑regulated industry that create, modify, maintain or transmit records electronically must adhere to Part 11:
Pharmaceutical, biotechnology and medical device companies
Contract research organizations (CROs), contract manufacturing organizations (CMOs) and clinical trial sponsors
Laboratories (LIMS, ELN, LES, QC and R&D)
SaaS providers and software vendors serving regulated customers
Digital health technologies and electronic data capture systems used in clinical investigations
Risks of Non‑Compliance
Regulatory and Enforcement Risk
Financial Risk
Reputational Risk
Data Integrity and Product Quality Risk
Security Control Risk
Market Credibility and Stakeholder Trust
Strategic and Competitive Risk
Common Gaps
1. Incomplete Validation
2. Missing or Tamper‑Prone Audit Trails
3. Shared Logins and Weak Access Controls
4. Poor SOP Documentation and Training
5. Inconsistent Electronic Signature Practices
Core Requirements
To achieve compliance, systems must include several controls and features. A risk‑based approach to validation is encouraged
System Validation
Systems used to create or modify records must be validated to ensure accuracy, reliability and consistent performance.
Audit Trails
Secure, computer‑generated, time‑stamped audit trails must capture who did what and when.
Access Control
Only authorized individuals should access the system. Unique user IDs, strong authentication and role‑based permissions are required.
Electronic Signatures
Electronic signatures must clearly identify the signer, include the date/time and indicate the meaning of the signature.
Record Retention & Retrieval
Systems must generate accurate copies of electronic records and ensure they can be readily retrieved throughout their retention period.
Standard Operating Procedures (SOPs)
SOPs should cover system usage, signature controls, security administration, record retention, backup and user training.
Steps to Readiness
Gap Assessment
Inventory systems, identify GxP records, rank risks and spot immediate fixes.
Remediation Plan
Define controls, enable audit trails, configure access, draft SOPs and remediate gaps.
Validation Execution
Perform and document tests, build traceability, summarize deviations and approve results.
Handover and Training
Deliver the validation package, train users, schedule periodic reviews and prepare for audits.
Ensure Compliance with FDA Standards
We take an end-to-end, meticulous approach to FDA 21 CFR Part 11. By combining seasoned experts with innovative solutions, we make compliance seamless and measurably lower your regulatory risk.
FAQs
Find straight answers to key questions about 21 CFR Part 11 controls, records, and audits.
The FDA does not grant a "21 CFR Part 11 certificate." Compliance is demonstrated through inspections and evidence, not by obtaining a license or seal.
Yes. Part 11 is technology‑agnostic; it applies to any system that creates or stores records regulated by the FDA. Organizations remain responsible for validating cloud systems, safeguarding data integrity and security, and selecting vendors that provide evidence such as SOC 2 or ISO 27001 certifications and disaster‑recovery documentation.
Responsibility for electronic records and signatures always rests with the product license holder. While CMOs may run systems on your behalf, your quality agreement should define who handles validation, audit‑trail review and backup retention. Marketing claims of being “Part 11 ready” are not a substitute for demonstrable compliance.
The FDA does not certify software for Part 11. Compliance depends on how the software is configured, validated and used in your environment. Organizations must validate systems themselves and implement procedural controls such as audit trails, access control and change management. Relying solely on vendor assurances is a common compliance mistake.
Beyond audit‑trail checks, organizations should review user permissions quarterly, conduct semi‑annual audit‑trail reviews, perform annual system assessments, and revisit procedures whenever regulations or systems change. Annual reviews modeled on Annex 11 help demonstrate continuous oversight and readiness for inspections.