Computer System Validation is a regulatory requirement under ICH GCP and 21 CFR Part 11 but it also makes good business sense to ensure that computerized systems will perform consistently as expected.
Non-compliance issues show that users find dealing with computer systems challenging. Quality management of computer systems (hardware and software) is a central part of the overall quality management ...
Shifting guidance and the growing prominence of computer software assurance exemplify the state of computer software validation. The exact state of computer software validation (CSV) can be tricky to ...
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