Validation of computerised systems across planning, risk assessment, testing and documentation, through to audit readiness.
What the engagement covers
Scope
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01
Validation Planning
Validation master plan, system inventory and the scope of what will be qualified.
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02
Risk Assessment
Risk-based determination of test depth, driven by patient safety, product quality and data integrity.
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03
System Testing
Installation, operational and performance qualification executed against approved protocols.
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04
Documentation
The protocol, execution evidence, traceability matrix and summary report set.
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05
Audit Readiness
Review of the completed package against what an inspector will ask to see.
Contact Now
Discuss your computer system validation (csv) requirement
Tell us the systems in scope and your inspection timeline, and we will propose an engagement.