21 CFR is legislation contained in the Federal Food, Drug, and Cosmetic Act. This includes rules on how drugs and medical devices are developed and manufactured. The rules also cover cosmetics and other items such as tobacco products.
21 CFR Part 11 is the Federal Drugs Administration’s (FDA) regulations for electronic documentation and electronic signatures. It is designed to ensure that electronic records are reliable and, in the past, provided guidance migrating from paper records to electronic ones.
Good Manufacturing Practice (GMP) is closely related to 21 CFR Part 11 and provides detailed guidance on high quality manufacturing. In addition to FDA mandated GMP the EU requires a wide range of products to comply with ISO 22716 for GMP. All these rules are different for drugs, medical devices, cosmetics and tobacco. With a huge number of source documents, it is easy to become confused.
However, both US, European and worldwide rules have a number of items in common, especially a requirement for robust record keeping. 21 CFR Part 11 is largely the set of requirements that you need for a robust and well designed system. They include functionality such as audit trails, digital signatures and role based security and it should possible for most modern systems to meet the requirements.
Many activities in life sciences are performed on spreadsheets. This is because clinical trials and early stage manufacturing is work in progress and will be developed and refined over time. Often it is not clear whether it is worth investing in a permanent infrastructure until the product has gone to market.
Spreadsheets are fast, flexible and easy to develop. However a native spreadsheet does not meet the Part 11 requirements such as audit trails and role based security.
Spreadsheets can be made Part 11 compliant with appropriate software tools and an effective validation process.
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