What is 21 CFR Part 11?
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21 CFR Part 11 refers to Title 21 of the Code of Federal Regulations (CFR), Part 11, which outlines the regulations set by the U.S. Food and Drug Administration (FDA) regarding the use of electronic records and electronic signatures in various industries, particularly in the context of the pharmaceutical, biotechnology, and medical device sectors.
The main objective of 21 CFR Part 11 is to ensure the authenticity, integrity, and reliability of electronic records and electronic signatures used in FDA-regulated industries. This regulation became particularly significant as technology advanced and electronic systems began to replace traditional paper-based systems for record-keeping and documentation.
Key elements of 21 CFR Part 11 include:
1. Scope: The regulation covers electronic records and electronic signatures used in FDA-regulated activities, such as clinical trials, manufacturing, quality control, and laboratory operations.
2. Electronic Records: Part 11 outlines requirements for the creation, modification, maintenance, and retention of electronic records. These records can include various types of documents, such as clinical trial data, laboratory results, and manufacturing records.
3. Electronic Signatures: The regulation defines the requirements for electronic signatures, which are digital equivalents of handwritten signatures. Electronic signatures are used to indicate approval, authorization, or review of electronic records.
4. Validation: Part 11 mandates the validation of electronic systems and processes to ensure that they meet the required standards for accuracy, reliability, and security. This validation process involves demonstrating that the system consistently produces accurate and reliable results.
5. Security Controls: The regulation requires the implementation of appropriate security controls to protect electronic records from unauthorized access, tampering, and data breaches. This includes user authentication, access controls, and audit trail mechanisms.
6. Audit Trails: Electronic systems covered by Part 11 should have audit trail capabilities to record and retain a secure record of all actions taken with electronic records and electronic signatures.
7. Record Retention: Part 11 specifies the requirements for record retention periods and the methods for ensuring records are accessible and legible throughout their retention period.
8. Electronic Copies of Records: The regulation allows for the use of electronic copies of paper records, provided certain requirements are met.
21 CFR Part 11 compliance is particularly relevant to companies involved in the development, manufacturing, and distribution of FDA-regulated products. Non-compliance with these regulations can result in regulatory actions and penalties. Therefore, organizations subject to FDA oversight must ensure that their electronic records and electronic signatures meet the requirements outlined in 21 CFR Part 11 to maintain data integrity, security, and regulatory compliance.
