Understanding the Differences: 21 CFR Part 11 vs. Annex 11

Two key regulations that pharmaceutical and medical device companies need to be compliant with are 21 CFR Part 11 and Annex 11, which are crucial to ensure product quality, safety and data integrity. While both regulations are aimed at ensuring the integrity of electronic records and electronic signatures, they differ in their scope, requirements, and application.

What is 21 CFR Part 11?

21 CFR Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA) that establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.

Key Requirements of 21 CFR Part 11:

• Validation of Systems: Electronic systems used in the creation, modification, maintenance, retrieval, or transmission of electronic records must be validated.
• Audit Trails: Systems must have the capability to generate accurate and secure audit trails to record all actions that create, modify, or delete electronic records.
• Electronic Signatures: Electronic signatures must be unique to the individual, must not be reused, and must be linked to their respective electronic records.
• Record Retention: Electronic records must be maintained in accordance with applicable FDA regulations and must be readily retrievable throughout the record retention period.
• Access Control: Systems must have appropriate controls to prevent unauthorized access to electronic records and electronic signatures.

What is Annex 11?

Annex 11 is a part of the European Union’s Good Manufacturing Practice (GMP) guidelines for medicinal products for human and veterinary use. It specifically addresses the use of computerized systems and electronic data in GMP-regulated environments.

Key Requirements of Annex 11:

• Validation of Systems: Computerized systems must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
• Audit Trails: Systems must have the capability to generate complete and accurate audit trails to record all critical events.
• Electronic Signatures: Electronic signatures must be implemented in compliance with EU legislation and must be uniquely linked to the individual, secure, and controlled by the signer.
• Data Integrity: Measures must be in place to ensure the integrity and reliability of data throughout its lifecycle, including creation, modification, and deletion.
• Access Control: Access to computerized systems must be restricted to authorized individuals and must be traceable through the use of unique identifiers.

Key Differences Between 21 CFR Part 11 and Annex 11

Conclusion

While both 21 CFR Part 11 and Annex 11 aim to ensure the integrity of electronic records and electronic signatures, they differ in their scope, requirements, and application. Companies operating in the pharmaceutical and medical device industries must understand these differences to ensure compliance with the relevant regulations in their respective markets.

For companies operating globally, it is crucial to be aware of the requirements of both regulations and to implement robust electronic record and electronic signature systems that comply with both 21 CFR Part 11 and Annex 11 to maintain compliance and ensure product quality, safety, and data integrity.

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