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Annex 1 | Risk Based approach to Qualification Activities
In the last few year the focus on qualification activities has been constantly moving from a system’s strict qualification path including IQ, OQ and PQ after commissioning to applying a risk based approach to qualification activities in order to make as much leverage as possible on vendor documentation and testing, performed either at vendor facility and customer site. The updated approach foresees a lifecycle approach to systems and a continuous challenge of the systems to maintain the qualification status under control and prevent the obsolescence of the system itself. The “integrated” strategy based on CQA and CPP is here explained and analyzed.”
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