Computer-based systems in Pharmaceutical and Life Sciences industries are subject to FDA’s Computer system validation (CSV) and Computer software assurance (CSA) (ref. FDA’s CFR 21 part 820.70(i)). Both are fundamental, mandatory processes that ensure and document that a computer-based system works in a consistent and reproducible manner according to its design. They aim to demonstrate that the computer-based system satisfies, during its employment, a set of defined prerequisites.
STAEDEAN Life Sciences extend Microsoft Dynamics 365 Finance & Supply Chain Management with the Life Sciences Cloud Compliance Suite module, which provides specific features for the automation of the Microsoft Dynamics 365 Finance & Supply Chain Management validation process.
Among other features, the Life Sciences Cloud Compliance Suite introduces:
Export data structure, a tool that allows for exporting the structure of tables and entities of a Microsoft Dynamics 365 Finance & Supply Chain Management instance.
Export security, a tool that allows exporting the security configuration of a Microsoft Dynamics 365 Finance & Supply Chain Management instance.
Export data pack, a tool that allows producing the documentation of a Microsoft Dynamics 365 Finance & Supply Chain Management environment configuration.
Compare data packs, a tool that allows comparing the configurations exported from different Microsoft Dynamics 365 Finance & Supply Chain Management environments and documenting their differences.
This user guide describes how to configure and use features available in Life Sciences Cloud Compliance Suite. The features are grouped by functional area: