What mean to be compliant with CFR 21 Part11

The cornerstones of FDA compliant software validation

Compliance with CFR 21 (Code of Federal Regulations Title 21) means that a company or organisation complies with the regulations of the US Food and Drug Administration (FDA) for the manufacture, processing, packaging and distribution of food, drugs, medical devices and cosmetics. Compliance with CFR 21 ensures that products are safe, effective and of high quality. Companies can face legal penalties, fines and even product recalls if they fail to comply.

What does it mean to be Part11 compliant?

Part 11 compliance" refers to compliance with the regulations outlined in Part 11 of Title 21 of the Code of Federal Regulations (CFR), which establishes the criteria for electronic records and electronic signatures used in FDA-regulated industries. Specifically, it requires electronic records to be trustworthy, reliable and equivalent to paper records, and electronic signatures to be authenticated, secure and legally binding. Companies involved in the manufacture, testing, distribution and sale of FDA-regulated products, such as drugs, medical devices and biologics, must comply with Part 11.

The difference between cfr21 and part 11

CFR 21 and Part 11 are two regulatory guidelines from the US Food and Drug Administration (FDA) which relate to electronic records and signatures in the pharmaceutical industry.

CFR21, or Title 21 of the Code of Federal Regulations, is a set of regulations that outlines the requirements for manufacturing, processing and distributing pharmaceuticals and medical devices in the United States. CFR21 regulations cover various aspects of the manufacturing process, including quality control, testing, labelling and record keeping.

Part 11, on the other hand, is a specific section of CFR21 that relates to electronic records and signatures. Part 11 sets out the requirements for electronic records and electronic signatures to be considered as legally valid and equivalent to paper records and handwritten signatures. It also sets out the criteria for the reliability, accuracy and security of electronic records.

In summary, CFR21 is a broader set of regulations covering various aspects of the pharmaceutical manufacturing process. Part 11 is a specific section of CFR21 that deals with electronic records and signatures.