Could someone explain to me or point in the right direction for what CFR 21 Section 11 requirements in a product (such as a disk storage system) for it to be compliant.
I think this is about records and electronic signature authentication and has something to do with the FDA (CPG 7153.17). It would seem to be more of an application feature than a hardware requirement? We are caught ignorant on this one and I dont have a copy of the CFR 21, much less CPG 7153.17 (?!). We have found some info, but our layman understanding doesnt answer the question of what/how to comply. Anybody? Respectfully, Kyle Ehler <mailto:kyle.eh...@lsil.com> Assistant Design Engineer LSI Logic Storage Systems Div. 3718 N. Rock Road U.S.A. Wichita, Kansas 67226 Ph. 316 636 8657 Fax 316 636 8321
