FDA 21 CFR Part 11 & GAMP 5: Overview and Compliance

 

FDA 21 CFR Part 11 & GAMP 5: Overview and Compliance

1. FDA 21 CFR Part 11 – Electronic Records & Signatures

Scope: Applies to electronic records and signatures in FDA-regulated industries (pharma, biotech, medical devices, etc.).

Key Requirements:

• Electronic Signatures: Must be unique, verifiable, and legally binding.

• Audit Trails: Systems must maintain secure, time-stamped audit trails for record changes.

• Data Integrity: Ensures accuracy, reliability, and protection against tampering.

• Validation: Systems must be validated to ensure accuracy, consistency, and reliability.

• Access Controls: Restrict system access to authorized personnel.

• Records Retention: Electronic records must be securely archived and retrievable.

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2. GAMP 5 (Good Automated Manufacturing Practice)

Published by ISPE, GAMP 5 provides a risk-based framework for compliant computerized systems in pharma and regulated industries.

Core Principles:

• Product & Patient Focus: Ensure patient safety and product quality.

• Risk-Based Approach: Focus validation efforts on critical systems.

• Lifecycle Approach: Covers system development, operation, and retirement.

• Supplier Involvement: Leverage supplier documentation where possible.

• Scalability: Tailor validation based on system complexity and risk.

GAMP 5 Categories for Software:

• Category 1: Infrastructure software (e.g., OS, databases).

• Category 3: Non-configured software (e.g., off-the-shelf tools).

• Category 4: Configured software (e.g., ERP, LIMS).

• Category 5: Custom-developed software.

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3. How GAMP 5 Supports 21 CFR Part 11 Compliance

• Validation: GAMP 5 guides compliant system validation (required by Part 11).

• Risk Assessment: Helps identify Part 11-critical functionalities (e.g., audit trails, e-signatures).

• Documentation: Provides templates for specifications, testing, and reporting.

• Supplier Assessment: Ensures third-party software meets regulatory expectations.

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4. Best Practices for Compliance

• Conduct a risk assessment to prioritize Part 11/GAMP 5 requirements.

• Implement electronic signatures with biometric or multi-factor authentication.

• Ensure audit trails are immutable and review them periodically.

• Validate systems per GAMP 5 guidelines (e.g., URS, FDS, IQ/OQ/PQ).

• Train staff on data integrity and Part 11 requirements.

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5. Key Differences

Aspect	21 CFR Part 11	GAMP 5
Focus	Legal compliance (electronic records/signatures)	Best practices for system validation
Regulatory vs. Guidance	FDA regulation (mandatory)	Industry guideline (non-binding)
Scope	Specific to FDA-regulated sectors	Broader (global, multiple regulators)

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Conclusion

• 21 CFR Part 11 sets legal requirements for electronic records/signatures.

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• GAMP 5 provides a practical framework to achieve compliance through risk-based validation.

• Combined, they ensure data integrity, regulatory compliance, and efficient validation in regulated environments.

For implementation, align system validation (GAMP 5) with Part 11’s technical controls (e.g., audit trails, access security).

Would you like details on a specific aspect (e.g., validation protocols, audit trail requirements)?