Computer System Validation, Online
2018-09-19
Validation of computer system software is completely different than validation of device software (embedded software). Attempting to conduct a CSV following device software validation concepts could result in a 483 or rejection of a product approval submission. You will learn in detail: · Validation life cycle models and Validation Plan contents · How to determine the complexity category of your system based on GAMP 5 principles · How to evaluate risk level using GAMP 5 modifications to the ISO 14971 procedure · What level of testing is necessary based on software complexity and risk · Integrating software supplier evaluation into the validation process · What requirements documentation is necessary · How to plan and conduct IQ, OQ and PQ Areas Covered in the Session : · Validation strategy · Requirements documentation · Complexity and risk analysis · Creating a detailed test plan based on risk · Supplier qualification · IQ, OQ and PQ Who Will Benefit: · Computer system developers · Systems development engineers · QA/ QC · Lab Managers and Analysts · Production Managers · Engineering managers
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