The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical device production. FDA said the draft ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

The life sciences industry faces a defining inflection point. FDA’s Computer Software Assurance (CSA) framework, GAMP© 5 Second Edition, and the broader shift toward risk-based approaches are ...

The US Food and Drug Administration’s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...