Electronic quality management system (eQMS)

An electronic quality management system is the digital equivalent of a traditional, paper-based quality management system. Current technological developments are pushing medical device manufacturers to transition to an eQMS and leave behind outdated methods, where paper is used to keep track of all content and processes in the development and manufacturing of medical devices. An eQMS is essential for ensuring compliance with Good Practice (GxP) regulations and is mandatory by law. It contains a series of different areas of focus like: equipment, deviations, audits, and CAPA (corrective and preventive actions, complaints, change control, suppliers, and training).

An eQMS is a roadmap to creating safe and effective medical devices. How does structured content help? Structured content helps simplify the authoring and updating of information for documents that end up in the eQMS. Not only is it a digital approach, but structured content goes one step further and helps medical writers to have component-level control over the content, as opposed to a document-level one when dealing with a classic word processor. Document owners can define granular content components and reuse them across the documentation. Updating content takes much less with a structured content approach, as the content that needs to be changed throughout the documentation can automatically change by updating the source. A structured content solution integrated with an eQMS, allows medical device organizations to publish the final documentation in the eQMS – ensuring a direct connection between the authoring environment and the final document repository environment.

Key benefits

• Achieve a 100% reliable audit trail

• Streamline content operations from Design History Files to regulatory submissions

• Increase security by using a single integrated authoring solution for all stakeholders

• Quick content updates with single sourcing