Can anyone explain what is meant by this clause (validation of the application of computer software)? Is it solely in relation to software systems that are used in production or is it in relation to material management software, MS Access databases and excel spreadsheets which are use for the collection/trending of data? Am I confusing this requirement with 21 CFR Part 11? What would be the content of a typical procedure on the validation of the application of computer software?
Thanks in advance!
Thanks in advance!