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PAS-X SERVICES
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| Validation Support |
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Validation is a crucial element in introducing a computerized system for use in a regulated environment:
- Review of the customer's QM system in terms of computer system validation requirements
- Identification of the required documents and agreement on methods to be used for writing them
- Preparation of a validation plan
- IT risk analysis and description of computerized business processes
- Test specification and implementation:
- Use of tools to provide complete transparency of traceability
- IQ based on the installation plan and system manual
- OQ based on the business process description and risk analysis
- PQ based on the User Requirements Specification
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