THE CHALLENGE
Stereotaxis was managing change control processes using a manual paper-based solution. A separate document control solution that was used was not only inadequate for the company’s growing needs but it also was not integrated into the quality and compliance processes.
THE SOLUTION
Dot Compliance QMS Xpress was deployed, and the ease of configuration allowed Stereotaxis to match quality and compliance processes with business requirements. As a result, user adoption was seamlessly rolled out. The company deployed Change Control, Document Control, and Training Management. The solution allowed Stereotaxis to automate the release of controlled documents, create and automate training assignments, and index change controls and documents.
NEXT STEPS
Given the robustness of these processes, the company is looking to expand process automation and move more QMS processes into Dot Compliance
- Complaint Handling
- CAPAs
- Nonconformance Reporting
- Deviations/Waivers
- Vendor Controls
