Computer System Validation
Introduction
This whitepaper is intended as a guide to assist your organization with Computer System Validation (CSV) and provides an overview of CSV methodologies and a road map of deliverables used in the CSV process. As computer systems are diverse, depending on the type and size of system, novelty, complexity and business impact, the deliverables may be scaled up or down accordingly. The CSV process discussed in this whitepaper is based on the GAMP 5 framework, as it provides an excellent and pragmatic approach for CSV which, when followed, will ensure your computerized systems are fit for purpose, will meet the needs of your business, and are compliant with current regulations.
Validation Process
The range of activities required to validate a computerized system are determined by its GAMP 5 software and hardware categorization, GxP impact, applicable electronic records and electronic signatures requirements,and its risk-based lifecycle approach. There are four life cycle phases of a computer system which are employed by GAMP 5 - concept, project, operation and retirement. Various activities take place in more than one phase, hence a fifth phase, multi-phase, is documented here to describe these cross-phase activities.
Concept Phase
System Software and Hardware Categorization
The following GAMP 5 software and hardware categories are used to establish the validation approach and determine the deliverables:
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Category 1 – Infrastructure Software
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Category 3 – Non-Configured Products
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Category 4 – Configured Products
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Category 5 – Custom Applications
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Hardware Category 1 – Standard Hardware Components
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Hardware Category 2 – Custom Built Hardware Components
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