Engineering Domain : Product Life Cycle Management Prerequisites : CPF MatrixOne 10 | PRG MatrixOne 10 Available since : 2007-12-12,
A best-in-class change control system is critical for promoting innovation and growth while maintaining costs and reducing regulatory risk. A change control system for effectively managing document changes, design changes and production process changes is at the heart of every quality system and a crucial element of regulatory compliance. The complex changes management processes involve a myriad of elements - specifications, procedures, test methods - that must be carefully coordinated and verified throughout the change process. Life Sciences companies must adequately assess and validate the impact of changes, but are hamstrung by poor assesment methods, complex procedures and inadequate approvals. Moreover, manual steps in executing changes increase the likelihood of error. The ENOVIA Life Sciences Accelerator for Change Control provides Life Sciences companies the ability to effectively manage the change process from request to implementation and closure while ensuring the proper process is followed every time and change activities are completed according to plan.
Provides a flexible, ready-to-use business process for managing changes to all documents, procedures and specifications through a single, robust Change Control process.
Interacts seamlessly between the Change process and other ENOVIA PLM processes such as CAPA, Product Development and Supplier Control.
Automatically enforces critical change control process steps to reduce regulatory risk. Also, gives the assesment of the Regulatory, Safety, and the Financial impact of change.
Enforces Part 11-complaint approvals for changes based on a company-defined approval matrix to achieve a more reliable change process.