21 CFR Part 11

21 CFR Part 11, often referred to as simply "Part 11," is a regulation established by the U.S. Food and Drug Administration (FDA) that sets forth guidelines for the use of electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries. Specifically, it outlines the requirements for ensuring the authenticity, integrity, and reliability of electronic records and signatures used in FDA-regulated activities.

 

Key provisions of 21 CFR Part 11 include:

1. Scope: Part 11 applies to all FDA-regulated industries, including pharmaceutical manufacturing, clinical trials, medical device manufacturing, and biotechnology.

2. Electronic Records: Part 11 defines electronic records as any combination of text, graphics, data, audio, pictorial, or other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computerized system.

3. Electronic Signatures: The regulation defines electronic signatures as electronic sound, symbol, or process that is attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record.

4. Requirements for Electronic Records:

a)    Electronic records must be accurate, reliable, and maintained securely.

b)    There must be controls in place to ensure the authenticity and integrity of electronic records.

c)     Access to electronic records must be restricted to authorized individuals.

d)    Electronic records must be protected from unauthorized alteration or deletion.

5. Requirements for Electronic Signatures:

a)    Electronic signatures must be unique to the individual and should not be shared.

b)    The system must ensure that the electronic signature is linked to the correct individual.

c)     There must be controls to prevent the unauthorized use of an individual's electronic signature.

6. Audit Trails: Systems covered by Part 11 must generate and maintain audit trails that record changes and entries. Audit trails must be secure, time-stamped, and human-readable.

7. Validation: Systems used for electronic records and electronic signatures must be validated to ensure that they operate reliably and consistently in compliance with regulatory requirements.

8. Record Retention: Records must be retained in accordance with applicable FDA regulations, and they must be readily retrievable during inspections.

9. Paper Copies: Part 11 permits the use of paper printouts as "trusted copies" of electronic records, provided certain conditions are met.

 

21 CFR Part 11 was established to facilitate the transition from paper-based systems to electronic record-keeping in FDA-regulated industries while maintaining the integrity and security of data. Compliance with Part 11 is essential for companies operating in these industries, as non-compliance can result in regulatory actions and legal consequences. Pharmaceutical companies, in particular, rely on Part 11 compliance to ensure the accuracy and traceability of electronic data throughout the drug development and manufacturing process.