Computer System Validation (CSV)
By utilising our expertise in GAMP and adhering to industry best practices for Computerised System Validation, we offer risk-focused validation services that are tailored to both small and large systems.
Our extensive experience spans the validation of computer systems across the GxP spectrum, including laboratory information management systems, manufacturing materials management and dispensing systems, clinical trial management, regulatory document submissions (CTD/eCTD), pharmacovigilance systems, and infrastructure services such as IT service desks, data centres and networks.
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Featured case studies
Medical device CSV
Medical device CSV Introduction IVD manufacturer The client is an IVD manufacturer based in Europe. Although already ISO 13485:2016 certified, they were agnostic when it came to GAMP 5 and 21 CFR PART 11. They have 80 employees based over 2 sites in France. Apotech consultant: Apotech’s consultant coordinated 5 technicians, acting as project manager…