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We ensure that your system is functioning correctly, meets regulatory requirements, and can be relied upon to manage critical processes as we help you identify and mitigate errors and compliance issues before they become problems. That’s why some of the world’s most essential manufacturers turn to us for support.
With our extensive knowledge of ERP systems, standards, and regulations, you can count on us to accurately streamline the validation process and deliver a seamless implementation. At the end of the project, you’ll receive a comprehensive set of easy-to-understand deliverables to share with inspectors.
ERP system validation is essential for many industries, including medical manufacturing, life sciences, and pharma. Our risk-based approach leverages GAMP5, an established methodology, to make sure your system’s most critical areas are properly identified, prioritized, and tested.
Our Experience
At PV, we have experience validating a wide range of ERP systems for our clients. Our team provides expert knowledge of FDA regulations and requirements, including 21 CFR Part 11, to ensure we deliver a successful validation. We focus on testing only what is required, ensuring we meet our client’s needs while minimizing testing redundancy. Throughout the entire project, our clients receive frequent, clear and detailed updates on the project status to help eliminate the stress during the validation process.
CSV Services Manager -
With over ten years of experience, Kevin spearheads our day-to-day operations within our Computer System Validation division. Kevin has a wide range of experience with life cycle documentation development and execution plans to ensure systems meet regulatory and intended use requirements
CSV Services Manager -
With over ten years of experience, Kevin spearheads our day-to-day operations within our Computer System Validation division. Kevin has a wide range of experience with life cycle documentation development and execution plans to ensure systems meet regulatory and intended use requirements