About this document
URS Format for GMP Systems in Pharma by RainMan75 is a document available to read on EtoBox.
The user requirements specification (URS) for a computerized control system addresses 31 key areas including the scope, objectives, regulatory requirements, process overview, system boundaries, operations, design data, instrumentation, data records, functions, software, hardware, interfaces, environment, security, diagnostics, availability, safety, testing, quality, development lifecycle, documentation, training, engineering standards, ongoing support, warranty, delivery requirements, and newly sanctioned s
- Author
- RainMan75
- Language
- EN