The requirement to perform regular Product Quality Reviews (PQRs) is mandated in most codes of Good Manufacturing Practice. For most of these, the frequency of these reviews is to be at least annually.
If you work at a regulated company, then there is a fair chance that you have heard of the term computer system validation (CSV). The issue is that a “computer system” is technically the hardware and software of a platform system. Around that you need to add application software, ancillary equipment, people and procedures to form a...
There are many phases in a computerised system project and all are important, but none more so than gathering User Requirements.