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 ...

Highly regulated life science labs that operate under quality systems like Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), or Good Clinical Practice (GCP) must document that the lab ...

Computer software assurance (CSA) is now FDA's recommended framework for validating production and quality system software, replacing the documentation-heavy computer system validation (CSV) model ...

Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...