Регуляторные требования к валидации компьютеризированных систем

Требования к валидации компьютеризированных систем представлены в следующих нормативных документах:

• The Rules Governing Medicinal Products in the European Union. Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use. Annex 11. Computerised Systems. Rev. January 2011.
• CFR Part 11 – Electronic Records; Electronic Signatures
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals
• CFR Part 820 – Quality System Regulation
• GAMP 5: GAMP Guide for Validation of Automated Systems (A Risk Based Approach to Compliant GxP Computerized Systems), ISPE March 2008
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff, FDA CDRH January 2002
• Glossary of Computerized System and Software Development Terminology, FDA ORA August 1995
• Guidance for Industry 21 CFR Part 11; Electronic Records; Electronic Signatures, Scope and Application, FDA, August 2003 Final Guidance
• PIC/S Good Practices for Computerised Systems in Regulated “GXP” Environments (PI 011-3) Sept 2007
• IEC 60601-1-4 Medical electrical equipment. Part 1-1. General requirements for safety. Safety requirements for medical electrical systems. April 1, 2000.
• IEC 61506:1997. Industrial-process measurement and control – Documentation of application software.
• IEC 61508. Functional safety of electrical/electronic/ programmable electronic safety-related systems. 1998.
• IEEE Std 1012. Standard for Software Verification and Validation.
• ISO/IEC 12119. Information technology — Software packages — Quality requirements and testing.
• ISO 14971. Medical devices — Application of risk management to medical devices. Part 1: Application of Risk Analysis.

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