FDA regulations require CSV/CSA approaches to validate software in pharmaceutical and life sciences companies. The validation process in GxP Computerized systems must follow GAMP5 requirements: the multi-step process involves documentation and testing software configurations, functionality, and user requirements.
Life Sciences Cloud Compliance Suite supports pharmaceutical and life sciences companies in the GAMP5 validation process at the configuration level. During the common software lifecycle, the configuration’s validation may be required multiple times (for example, when a new environment is deployed starting from an existing one when a backup copy of an environment is restored). The Life Sciences Cloud Compliance Suite allows for the documentation and comparison of Microsoft Dynamics 365 Finance & Supply Chain Management configurations among different legal entities or different Microsoft Dynamics 365 Finance & Supply Chain Management instances.