General Principles of Software Validation; Final Guidance for Industry and FDA Staff – PDF Download

Manostaxx - Industrial Management Consulting
Manostaxx – Industrial Management Consulting

This guidance outlines general validation principles that the Food and Drug Administration (FDA)
considers to be applicable to the validation of medical device software or the validation of software
used to design, develop, or manufacture medical devices. This final guidance document, Version 2.0,
supersedes the draft document, General Principles of Software Validation, Version 1.1, dated June
9, 1997.

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