Will the software affect the efficacy or purity of the drug?
The following key principles are outlined in GAMP and ISPE: gamp ispe
GAMP utilizes the "V-Model" for the software development life cycle (SDLC). Will the software affect the efficacy or purity of the drug
One of the most practical tools in GAMP is the categorization of software, which dictates how much validation is required. gamp ispe