FDA Validation 21 CFR Part 11

Since 2011, ENAXIS software (formarly ISOKEY) guarantees its clients compliance with the FDA 21 CFR Part 11 regulation.

The validation process is carried out using the GAMP methodology and in accordance with the requirements established by the FDA (US Food and Drug Administration) for the pharmaceutical industry in regulation 21 CFR Part 11.


CFR 21 Part 11 is a regulation established by the United States Food and Drug Administration (FDA) that establishes requirements for the use of electronic records and electronic signatures in computer systems that are subject to regulation under Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).


Some of the keys established by CFR 21 Part 11 include:

1. Electronic signatures:

Defines the requirements for the use of electronic signatures, including their authenticity, integrity and non-repudiation.

2. Electronic records:

Defines standards for the creation, maintenance and preservation of electronic records, ensuring their authenticity, integrity and readability.

3. System security:

Requires security measures to ensure the confidentiality, integrity and availability of electronic records.

4. Audit and traceability:

Defines requirements for conducting audits and the ability to trace changes made to electronic records.

CFR 21 Part 11 is crucial in regulated industries such as pharmaceutical, medical device, and food, as it provides clear guidelines on how to use computerized systems safely and in compliance with regulations. Compliance with these regulations is essential to ensure the quality and safety of products regulated by the FDA.