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  • merzkrashed replied to the topic Maintenance & validation in the forum Process Validation and Process Risk 7 years, 9 months ago

    As we learned from Simulation 2, ,the IQ, OQ, and PQ required for proper inspection. During the validation process all the data need to be analyzed and documented. You should analyze each input and fully verify the results. Validation is the process of making sure that you have objective evidence that user needs and intended uses are met. It is usually done by tests, inspections, and analysis. However, the target of the validation is to make sure the user needs are met in a medical device. A successful validation process would clearly define inputs and user needs to ensure that a product is properly validated.
    For your question, Do the manufacturer have to repeat IQ, OQ and PQ after the maintenance was performed?, you need to Quality Assurance test (like calibration) for the equipment, check(analyze) the results, then act according to the results. Also, its recommended to do PMs periodically for any equipment involved in the manufacturing process.