Hardware/software suppliers qualification

The purpose of performing a hardware/software supplier qualification is to assess the computing environments and technology products used to develop regulated applications. 

Operating Mannals need to be formally reviewed as fit for purpose by the supplier as they form the basis of User Procedures and User Qualification. Operating Manuals must be kept up to date with developments to the compnter systems to which they relate, and they mnst refer to specific hardware models and software versions making up the computer system being snpplied. Recommended ways of working defined by the snpplier should be verified as part of the development testing. 

The content of networks specification and test protocols will depend on the complexity of the system. For small systems it may be possible to incorporate the design of the network as a special section within the Systems Functional Specification, and similarly incorporate the network test cases as a special section within the systems. Operational Qualification Supplier audits for network hardware and software components are not usually necessary as these are normally industry standard. Further discussion in regard to supplier audits can be found in Chapter 7. 

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