Does a software supplier have to be audited at all events, or would it be sufficient if the supplier filled in a questionnaire which would then be assessed by the QA unit?

A software supplier has to be assessed at any rate. This can be done by means of an audit, but it is not absolutely necessary. The question whether a questionnaire is sufficient should be answered by the pharmaceutical entrepreneur in dependence on the criticality of the software, but also on experiences with the supplier. If the supplier “only” provides personnel working according to SOPs created by the customer, an audit is not necessary. However, it must be proved that these persons have been trained.