Scope and Application of 21 CFR Part 11: Electronic Records; Electronic Signatures The scope and application of 21 CFR Part 11, titled "Electronic Records; Electronic Signatures," are focused on regulating electronic records and electronic signatures within industries subject to FDA oversight. These industries include pharmaceuticals, biologics, and medical devices. Below are key points detailing the scope and application of this regulation: 1. Electronic Records >>>>>
- Part 11 pertains to electronic records that are created, used, maintained, archived, retrieved, or transmitted within regulated industries.
- Electronic records encompass various forms of digitally stored information, such as documents, data, and any electronically generated or stored content.
2. Electronic Signatures >>>>>
- This regulation governs the utilization of electronic signatures as the electronic counterparts to traditional handwritten signatures found on paper documents.
- Part 11 provides specific criteria and requirements for the use of electronic signatures in place of handwritten signatures.
3. Validation >>>>>
- Validation is a critical aspect when electronic records are employed for activities related to Good Manufacturing Practices (GMP).
- It ensures that electronic systems and associated software function as intended, producing accurate and reliable records.
4. Applicability to FDA-Regulated Industries >>>>>
- Part 11 is primarily applicable to industries subject to FDA oversight, including pharmaceutical manufacturing, biologics, medical devices, and other sectors where GMP compliance is mandatory.
- Industries outside the FDA's jurisdiction are not covered by this regulation.
5. Scope of Records >>>>>
- Part 11 encompasses a wide range of electronic records, including but not limited to:
- Batch records
- Clinical trial data
- Laboratory data
- Manufacturing and production records
- Quality control records
- Distribution and supply chain records
- Documentation associated with submissions to the FDA
6. Data Integrity and Security >>>>>
- The regulation underscores the significance of maintaining data integrity and security in electronic recordkeeping.
- Organizations are required to implement security measures to safeguard electronic records against unauthorized access, tampering, and data loss.
7. Audit Trails >>>>>
- Electronic systems subject to Part 11 must possess the capability to create and maintain audit trails.
- Audit trails comprehensively log and document all user actions related to electronic records, facilitating change tracking and ensuring data integrity.
8. Record Retention >>>>>
- Organizations must retain electronic records in accordance with relevant FDA regulations.
- Part 11 does not specify retention periods but mandates that records be readily available for inspection upon request by regulatory authorities.
9. Applicability to Electronic Copies >>>>>
- Part 11 permits the use of electronic copies of paper records, contingent on meeting specific criteria ensuring their trustworthiness and authenticity.
21 CFR Part 11 establishes the parameters for regulating electronic records and electronic signatures within FDA-regulated industries. Its objectives are to ensure the reliability, security, and integrity of electronic records while promoting the adoption of electronic systems in compliance with Good Manufacturing Practices (GMP) and regulatory standards. Compliance with Part 11 is imperative for organizations operating in these industries to meet FDA requirements and prevent regulatory violations.