What It Is
For labs in regulated industries, validation isn't optional—it's a requirement. This white paper provides a comprehensive guide to the IQ/OQ/PQ process, following the industry-standard GAMP 5 V-Model. It explains how to move from initial specifications to documented evidence that your system operates exactly as intended.
Who It's For
This resource is designed for validation specialists, quality assurance (QA) managers, and lab informatics project teams who need to produce defensible documentation for regulatory agencies.
How to Use It
Request this white paper to serve as your tactical validation handbook. Use the guide to structure your testing phases and define clear responsibilities. The guide also provides essential protocols for test execution, including how to handle deviations, why you should never execute scripts out of order, and the importance of training your testing team on Good Documentation Practices (GDP).
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