We have seen nearly every flavor of Quality Management Systems, and a wide variety of workflows for change control, deviations, complaints, etc. Projects often involve the reengineering of an existing QMS or targeted improvement of QMS elements such as Change Control and CAPA.

The benefits of QMS include:

• A QMS that is tailored to your company
• A QMS that is efficient and effective
• Roadmap to a mature Quality System
• Aligned with the expectations of FDA’s “PQS assessor”
• Remediate QMS elements to ensure “no weak QMS links”