21cfr part 11 is used for validating records 100 adult dating sites new

30 Dec

A: All computer systems which store data which is used to make Quality decisions or data which will be reported to the FDA must be compliant with 21 CFR 11.Dr Bob Mc Dowall is an analytical chemist with over 40 years experience, including over 30 years experience implementing and validating informatics solutions in regulated environments.He has a Ph D in forensic toxicology and 15 years experience working in the pharmaceutical industry.When implementing computerised systems, the requirements of Part 11 need to be fully understood.To help this, I want to explore the following areas in this blog post: Part 11 is a regulation that mandates controls for electronic records generated during the course of regulated activities or for records that are submitted to the FDA even if there is no stated requirement for the record in agency regulations.

However, do not be misled into thinking that there is a division between records and signatures – far from it. Sub-part B contains requirements for electronic signatures and sub-part C contains controls to ensure the integrity of electronic records as well as electronic signatures.