EyeQue Corp. Trusts Dot Compliance to Help Bring Eye Testing to Millions of People

THE CHALLENGE

EyeQue was using a file-based system to manage documents and training assessments.  They needed a quality management system that would grow with them and that was cost-effective.  Their initial goals were to automate document management and to build out a robust training process so they could manage employee training and exams.  Going from file-based to an automated quality system, it was imperative to have superior customer support with the right price tag. Compliance adherence was key.

THE SOLUTION

EyeQue successfully deployed Dot Compliance ready to use eQMS to digitize document management and training with integration between existing platforms, including Arena and ZenDesk. They are currently working on a new phase of their implementation to expand the use of Dot Compliance into design control and program management.  Since Xpress is based on the Salesforce platform, it will be easy to turn on additional functionality.

BENEFITS

Before Dot Compliance Xpress, training was given using Google Forms. Now it’s administered through the quality system and they have significantly streamlined training procedures and exams.  As a medical device company, EyeQue needs to remain compliant with FDA regulations and ISO standards, so additionally, they were able to build a standards library reducing the time it took to search for files.

Surmasis Pharmaceutical optimizes quality & compliance with Dot Compliance Xpress

THE CHALLENGE

Surmasis was managing their document and training management using a paper-based system. Unfortunately, this left them exposed to compliance risks. Other QMS systems previously piloted were not Part 11 compliant or they required advanced training for system administrators and software developers. They needed a simplified electronic quality management system (eQMS) to provide compliance but also visibility into their quality data, real-time, with dashboards and reporting capabilities.

THE SOLUTION

Implementing a pre-validated, off-the-shelf eQMS was their top priority. Dot Compliance’s cloud-based, ready-to-use quality and compliance management system with preconfigured best practices enabled Surmasis to deploy its processes within 30 days and budget. To avoid any customization, they were able to leverage the capabilities of protocols (electronic forms) which added critical data to records without having to generate required fields and revalidate their QMS.

NEXT STEPS

Surmasis continues to take advantage of Dot’s extensive set of quality processes by successfully deploying Changed Control, Complaints, and Corrective and Preventive Actions (CAPA) solutions as well as maintenance activities. Currently, they are working on Electronic Batch Record trials and design. Next on their schedule is to roll out Supplier Quality, Audits, and Quality Events processes.

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 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