For regulated industries operating to GMP or other GxP guidelines, software validation is essential. FDA dictates that to satisfy regulatory compliance it is necessary to validate all software used for the design, manufacture, packaging, labeling, storage, and servicing of all finished devices or products intended for human use. However, it’s not enough just to show that each piece of software reliably carries out its expected function.
Validation should consider the software infrastructure and how one piece of software might interact with and be instructed by or control other systems at every stage in a workflow. Only then is it possible to determine whether an individual software system satisfies regulatory standards for its intended use.
Download this white paper to learn more about software validation, courtesy of STARLIMS.