Off-The-Shelf Computer Systems

The validation documentation set provided by a supplier of COTS will be standard rather than being tailored in advance with the users. Nevertheless, pharmaceutical and healthcare companies should map supplier documentation to validation requirements in an attempt to satisfy the latter. This mapping may be quite complex, and a direct correlation impossible. However, at a minimum the mapping should cover  

Management of software development personnel Formal software development life cycle and associated documentation Programming standards Software fault management Documentation management Configuration control User manuals Release notes User support 

If the supplier s document set is insufficient to support the pharmaceutical or healthcare company s validation of the computer system, and the deficiencies cannot be remedied, then the system should not be used. 

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