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.
