21 CFR PART 11

21 CFR Part 11 is a regulation from the Food and Drug Administration (FDA) that establishes the requirements for electronic records and electronic signatures in the pharmaceutical industry. The regulation is designed to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records.

21 CFR Part 11 applies to records that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in FDA regulations. This includes records that are required to be maintained under the Current Good Manufacturing Practice (CGMP) regulations, the Good Laboratory Practice (GLP) regulations, and the Good Clinical Practice (GCP) regulations.

The key requirements of 21 CFR Part 11 include:

• System security:?The system used to create, modify, maintain, archive, retrieve, or transmit electronic records must be secure and protected from unauthorized access.
• Electronic signatures:?Electronic signatures must be used to sign electronic records in a way that ensures the authenticity, integrity, and confidentiality of the records.
• Record retention:?Electronic records must be retained for the same period of time as paper records.
• Access controls:?Access to electronic records must be controlled to ensure that only authorized individuals can access them.
• Validation:?The system used to create, modify, maintain, archive, retrieve, or transmit electronic records must be validated to ensure that it meets the requirements of 21 CFR Part 11.

21 CFR Part 11 is a complex regulation, and there are many resources available to help businesses comply with it. The FDA has published a number of guidance documents that provide more detailed information about the requirements of the regulation. There are also a number of third-party organizations that offer compliance services.

Compliance with 21 CFR Part 11 can be a challenge, but it is important for businesses that operate in the pharmaceutical industry. The regulation helps to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records. This is important for protecting the safety and quality of pharmaceutical products.