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Validation of Computer Software and GAMP 5 Guide

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Guest user Created:   Sep 25, 2019 Last commented:   Sep 27, 2019

Validation of Computer Software and GAMP 5 Guide

I have been reviewing your “Procedure for Documentation and Validation of Computer Software”, and want to know if it meets the ISO 13485 Computer System Validation (CSV) requirements?  Also, does it take the GAMP 5 Guide (Compliant GxP Computerized System) into consideration?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Sep 27, 2019

Although the Procedure for Documentation and Validation of Computer Software is written in general, it still covers all the necessary elements of CSV.

Considering GAMP5 following needs to be understood. GAMP 5 describes a set of principles and procedures that help ensure that pharmaceutical Software has required quality.

GAMP talks about “the How” and the ISO 13485 talks “the What” during the Validation of computer-based software for Pharma companies. GAMP is a methodology and Iso 13485 is a regulation. So to answer directly to your question – our procedure does not take all requirements from GAMP 5 into consideration.

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