Can you please provide any Policy/Standard/SOP for cGxP Computer Systems whose scope
can be applies to all Computerized Systems that support any oraganisation cGxP
processes, or create, modify, maintain, archive, retrieve or transmit electronic records
that address serve as a cGxP record.
The purpose of this that Policy/Standard/SOP can cover the requirements for Computerized Systems that impact activities related to current Good Manufacturing Practices (GMP), Good
Laboratory Practices (GLP) and/or Good Clinical Practices (GCP) collectively cGxP or
electronic submissions made to applicable regulatory agencies.