STAEDEAN Life Sciences extends D365 F&SCM with the Life Sciences Quality Control & Assurance module, which provides pharma-specific features for Quality Control and Quality Management.
Among other features, Life Sciences Quality Control & Assurance introduces:
Quality order approval workflows with a graphical interface, multiple levels of review, approval, and escalation, and a conditional release process.
Streamlined sample management, reduced testing policies, and accurate sampling plans based on a statistical approach.
Advanced specifications management (for example, versioning, optional test, statistical trend calculations).
Test criteria based on mathematical calculations with multiple steps in compliance with US, EMEA, Latin American, and Japanese regulatory requirements.
Robust integration to manage stability studies and environmental control analytical services with project management.
The features described in this user guide are clustered by functional areas: