Computer Systems Validation (Yellow Cover)

Kathryn DaviesSource NHS Pharmaceutical Quality Assurance CommitteePublished
This document is based on the North West Guidance Document on Computer Systems Validation. The Orange Guide 2002 Annex 11 introduced a requirement for validation of computer systems, which should comply with GAMP (good automated manufacturing practice) requirements.
This document gives guidance on how this can be achieved, but it is likely that the assistance of
local IT staff will be needed in carrying out some of the tests.

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