TrackWise QMS変更制御


TrackWise QMS変更制御は、最初のリクエストから変更適用まで、様々な部門にわたってプロセスを管理する上で役立ちます。変更を完了し、規制機関の承認を確保するために必要な作業とアクティビティをすべて整理します。 また、CAPA製品登録追跡など、他の品質プロセスと統合できます。 


Make structured changes that speed up quality.

Monitor and manage any type of change through various stages, including:

  • Initial request
  • Pre- approvals
  • Change execution
  • Follow- up approvals
  • Implementation
  • Audits

Document changes to increase visibility.

You can document changes as they occur to maintain visibility and control throughout the organization. This helps reduce your risk of failing to completely address a quality issue. Common types of changes logged include:

  • Batch
  • Documentation
  • EH&S
  • Equipment
  • Hardware/Network    
  • Materials
  • Packaging/Labels    
  • Process
  • Regulations    
  • Specifications
  • Supplier
  • Validation


Ensure quality and compliance.

Manage change at every level of the supply chain to ensure quality standards and compliance requirements are not affected. When changes are requested, all stakeholders can view the request and come to a consensus on the best course of action. 

Ready to streamline your change control process?

Schedule a Demo
© 1995-2021 Sparta Systems, Inc. All Rights Reserved.
© 1995-2021 Sparta Systems, Inc. All Rights Reserved.Sparta Systems Logo