Regulatory Compliance meets Manufacturing Excellence - MES enabling MDR compliant manufacturing
In highly regulated industries such as medical device manufacturing and biotechnology, the pursuit of operational excellence must seamlessly integrate with stringent compliance requirements. This Presentation explores how Manufacturing Execution Systems (MES), Statistical Process Control (SPC), and Advanced Recipe Management serve as foundational enablers of both manufacturing performance and regulatory / audit readiness.
By embedding compliance into manufacturing workflows, these systems ensure full traceability, real-time monitoring, release management and automated documentation, and by doing this transform many regulatory obligations from being an operational burden into an operational and strategic advantage.
Language of presentation: English
Hosted by VDMA HealthTech
Speakers (1)
Björn Bothur
Key Account Manager, camLine GmbH