21 CFR Part 11 Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry
Date de parution : 09-2019
17.8x25.4 cm
Date de parution : 01-2004
Ouvrage de 264 p.
17.8x25.4 cm
Thème de 21 CFR Part 11 :
Mots-clés :
CFR; SLC; computer; Computer Systems Validation; systems; Computer Technology Supplier; validation; PDA; electronic; Electronic Record; signatures; Validation Plan; records; Follow; plan; Fat; procedural; Contract Developer; control; Configurable Software Packages; audit; Electronic Signature Security; Message Digest; Applicable Predicate Rule; Standard Software Packages; Current Good Manufacturing Practice Regulations; Private Key; Corrective Action Plan; In-process Audits; Computer Validation; CSV; Software Life Cycle Processes; Program Build; Ongoing Monitoring Program; Code Reviews