Case Study: Reapplix achieves faster eQMS implementation and a successful digital audit with SimplerQMS

How did Reapplix impress auditors

Reapplix, a regenerative medicine company, faced the challenge of inefficient paper-based documentation for its quality management system (QMS) and design history file (DHF) as it began commercializing its 3C Patch® medical device. The company needed to digitize its processes but was concerned about the time and internal resources required for such a significant transition.

SimplerQMS implemented its eQMS solution through a gradual, three-step process to ensure a smooth transition for the busy organization. The implementation was completed successfully in about one month, and the Reapplix team was able to rely on the system's automatic notifications and efficient search functions. This preparation allowed them to pass their first digital audit with flying colors, impressing the auditor with their ability to provide crucial documents instantly.

Reapplix

Niels Erik Holm

Chief Operating Officer