| Influence of 21 CFR Part 11, Good Clinical Practice, Validation, and Regulatory Impact on Clinical Data Management Hauke Kindlera, Matthias Paskowskyb, and Wolfram Richterb Reliable Lifesciences Consultinga, Neuss, and IMPHAR AGb, Neuenhagen (Germany)
The Food and Drug Administration (FDA) rule 21 Code of Federal Regulations (CFR) Part 11 for electronic records and signatures came into force in 1997. The rule requires compliance for all computerised systems supporting processes that retrieve, create, modify, maintain, transmit, and archive electronic records and signatures for which FDA regulations (predicate rules) apply. 21 CFR Part 11 requests that such systems have to be validated. 21 CFR Part 11 is not apredicate rule and only applies if a company chooses to meet predicate rule requirements electronically. Data management processes underlie several predicate rules. As companies are working on implementing solutions for meeting the requirements stipulated by this rule, this article takes a look at the intentions of CFR 21 Part 11 and its interpretation today. A preview tries to predict future trends and developments.
Key words 21 CFR Part 11 • Clinical Data Management • Computerised Systems Validation • Good Clinical Practice |
