The use of computerized systems in regulated industries like pharmaceuticals, biotech, and medical devices is subject to rules issued by government regulatory authorities. In August 1997, the FDA issued a new rule, regulating the use of electronic records and electronic signatures (21 CFR Part 11, entitled “Electronic Records; Electronic Signatures – final rule”).
The rule 21 CFR Part 11 sets forth the requirements that computerized systems need to fulfill in order to allow electronic signatures and electronic records in lieu of traditional paper-based records and handwritten signatures.
21 CFR Part 11 has been developed with contributions of the pharmaceutical industry as this rule and its ongoing implementation will help to speed up the conversion process from elaborate and costly paper-based documentation towards electronic systems. In combination with the expected cost reduction, a shorter time to market and streamlining of research processes are further benefits. Regulatory authorities confronted with the ever-increasing number of new drug applications push the implementation of 21 CFR Part 11 to enable fully electronic regulatory submissions that allow a faster and more accurate approval process.
21 CFR Part 11 applies to all electronic data, documents and signatures that are created, maintained and archived in any GxP/FDA regulated environment. For the pharmaceutical industry as well as medical devices and product companies this affects primarily preclinical and clinical research, submission processes, production and post-marketing surveillance.
Currently 21 CFR Part 11 is legally binding for US manufacturers and suppliers and foreign companies, (e.g. from Europe) that offer products and services to the US market. Outside the scope of the US, compliance to 21 CFR Part 11 is not mandatory, but is becoming widely accepted as a new standard within the pharma industry worldwide. European regulations like EU GMP Annex 11 - Computerized Systems are widely comparable.