Case Studies

TopicStrategies for digital transformationBusiness process managementQuality, risk, (GxP) compliance management and continuous improvementProcess compliance and quality assurance for clinical trialsConcepts for and implementation of data governance / data quality / data integrityConcepts for handling electronic records and signatures (ERES)Process validation and qualification of equipment, plants or systemsValidation and operation of ERP systemsValidation of computerized systems (CSV) - clinical systems, laboratory systems, production systems, IT systems, medical technology, suppliers etc.IT infrastructure - qualification and complianceOther

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