What is 21 CFR Part 11? 

21 CFR Part 11 is a regulation issued by the United States Food and Drug Administration (FDA) that establishes the criteria for electronic records and electronic signatures used in the pharmaceutical, biotechnology, and medical device industries. The regulation sets forth the requirements for electronic records and signatures to be considered equivalent to paper records and handwritten signatures. 

The regulation was created to provide guidance to the industry on the use of electronic records and signatures in a manner that is compliant with FDA requirements for record-keeping, data integrity, and security. 21 CFR Part 11 applies to all FDA-regulated industries that use electronic records and signatures in their operations. 

The regulation requires that electronic records be accurate, secure, and available for retrieval and review. It also requires that electronic signatures be unique, identifiable, and secure, and that they have the same legal significance as handwritten signatures. 

To comply with 21 CFR Part 11, companies must have appropriate controls in place to ensure the security and integrity of electronic records and signatures. These controls include the use of access controls, audit trails, electronic signatures, and validation of electronic systems. 

In summary, 21 CFR Part 11 is a regulation that establishes the criteria for electronic records and electronic signatures used in the pharmaceutical, biotechnology, and medical device industries. It is designed to ensure that electronic records and signatures are equivalent to paper records and handwritten signatures in terms of accuracy, security, and availability. Compliance with 21 CFR Part 11 is essential for companies that are regulated by the FDA and use electronic records and signatures in their operations. 

Why 21 CFR is important? 

21 CFR (Code of Federal Regulations) is a set of rules and regulations that establish the requirements for the manufacture, distribution, and sale of drugs, medical devices, and food products in the United States. Compliance with 21 CFR is essential for companies operating in these industries as it ensures that their products are safe, effective, and of high quality. 

The regulations are designed to protect public health by setting standards for product quality, labeling, and packaging, as well as for manufacturing, processing, and storage conditions. They also require companies to have systems in place to ensure that their products meet these standards. 

For example, 21 CFR Part 211 sets out the requirements for the manufacturing and processing of drugs. It requires that manufacturers establish and maintain a quality control system that includes procedures for testing, release, and storage of products. Similarly, 21 CFR Part 820 sets out the requirements for the design, production, and distribution of medical devices, ensuring that these products are safe and effective. 

Compliance with 21 CFR is monitored by the FDA, which conducts inspections and takes enforcement action against companies that fail to meet the regulations. Non-compliance can result in product recalls, fines, and legal action, which can damage a company's reputation and financial standing. 

In summary, compliance with 21 CFR is essential for companies operating in the drug, medical device, and food industries in the United States. The regulations ensure that products are safe, effective, and of high quality, and non-compliance can result in serious consequences. Companies must have systems in place to ensure compliance with the regulations, and they must maintain a culture of quality to meet the standards set forth by 21 CFR.