Validation Regulations

sort by Title sort by   Date    Download  General Principles of Software Validation; Final Guidance for Industry and FDA Staff 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.  2002-01-11    PDF file (165 KB)  Validation Documentation Requirements and Responsibilities for Drug Fabricators, Packagers/Labellers, Distributors and Importers This guidance has been prepared to specify what documented evidence the Health Products and Food Branch Inspectorate (HPFBI) considers acceptable during an inspection, from drug establishments, to demonstrate compliance with validation requirements, Health Canada  2001-07-10    PDF file (23 KB)  Bioanalytical Method Validation This guidance provides a