There are several parts to the 21 CFR Part 11 documents with a good overview of 21 CFR Part 11 at the US FDA website. Part C is the key section concerned with electronic records retention. Continue reading
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FAQ: “ Is there anything that documents (certifies) that HunterLab EasyMatch QC-ER software and instruments conform to FDA 21 CFR Part 11 electronic records, electronic signatures (ERES)?” Continue reading