Computerized System Validation Support
In this project, QPS Engineering supported a pharmaceutical client in validating a newly introduced computerized system used in a GMP-regulated production environment. The scope covered the full CSV lifecycle, from initial system assessment to audit-ready documentation.
Our team developed a comprehensive, risk-based validation strategy based on GAMP 5 principles, ensuring full compliance with EU Annex 11 and 21 CFR Part 11. We collaborated closely with QA, IT, and system vendors to define user requirements, assess supplier documentation, and implement a traceable validation process.
Through detailed planning and efficient execution, QPS delivered a fully validated system that passed inspection without observations and integrated smoothly into the client’s existing quality management framework.
Scope of Services
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Gap analysis and vendor audit
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Validation Master Plan (VMP)
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URS, FS, DS creation based on business and regulatory needs
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Risk assessment (RA), traceability matrix, and test plan design
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Execution of IQ/OQ/PQ protocols
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Data integrity assessment and backup/restore verification
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Final report and audit preparation package