For a variety of reasons, software verification and validation has proven to be one of the more challenging and nebulous areas of compliance for companies regulated by FDA. Software, and how it is ...

Non-compliance issues show that users find dealing with computer systems challenging. Quality management of computer systems (hardware and software) is a central part of the overall quality management ...

Validate it? I just want to use it! Sound familiar? Most companies in the medical device industry understand and accept the need to validate software that is critical to the functioning of a medical ...

Shifting guidance and the growing prominence of computer software assurance exemplify the state of computer software validation. The exact state of computer software validation (CSV) can be tricky to ...