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Quality Management and Auditing

One of the life science industry´s most important areas of scrutiny are patient safety and product quality. These omnipresent principles require operations in a highly regulated environment. Therefore, computerized systems in support of regulated activities and data generated and maintained by these systems have to possess of certain quality characteristics in order to ensure a compliant setup. Moreover, the age of digitalization dictates new trends and tools, may it be cloud-based solutions or the use of artificial intelligence and machine learning components, which require new, creative ways of demonstrating your validation effort.

37 Centigrades AG can leverage year long experience in the setup of compliant computerized systems. We provide services such as validation and qualification concept development for complex systems landscapes, validation and qualification stream leads, risk assessments and risk-based validation and qualification architectures, as well as advisory and consulting services in dedicated areas of a validation or qualification initiative, may it be on the specification, IQ, OQ, or PQ side. In addition, we advise when the validated state has been lost and develop ways forward to reestablish. Last but not least, we are in permanent exchange with industry experts in search of points to consider when embracing latest trends and technologies. With good common senses we can advise on setups that can establish the validated state and can rather easily yet effective be maintained therein.

Furthermore, 37 Centigrades AG offers contract audits of software vendors as well as examining the validated state of dedicated system setups. Finally, we support customers in the harmonization and design of their quality-related business process landscape including selection of according tool support as needed.

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