CASE STUDY

Stereotaxis Automates Quality Process Coverage with Dot Compliance


THE CHALLENGE

Stereotaxis was managing change control processes using a manual paper-based solution. A separate document control solution which 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 of training assignments, and index of 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

ABOUT

Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory.


“Dot Compliance has helped us be more efficient in our processes, while also maintaining a high level of compliance in a highly regulated industry. I have no doubt that moving more QMS processes into Dot Compliance will allow the company to focus even more on technological innovations.”

– Adam Miller, Quality Manager