Medical Innovation Exchange

software validation

IQ OQ PQ and Its Role in Labeling System Validation

IQ OQ PQ and Its Role in Labeling System Validation     In highly regulated industries including medical device manufacturing, pharmaceuticals, and life sciences, regulatory authorities such as the FDA and the European Union (EU) have guidelines related to process validation to confirm a company’s processes will result in reliable outputs and meet all necessary quality …

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FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices

FDA Issues Draft Guidance on Computer Software Assurance for Medical Devices     On September 12, the FDA issued a new draft guidance, which provides recommendations on risk-based assurance activities for computers and automated data processing systems that are used as part of medical device production or the quality system. When finalized, “Computer Software Assurance for …

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