INSIGHTS ON QUALITY ASSURANCE

QUALITY ASSURANCE SOLUTIONS

  • Sterility is key for high-risk applications such as injectables, parenteral formulations, ophthalmic and peritoneal dialysis solutions, and many more.

  • The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.

  • Proactively manage risks of pharmaceuticals, medical devices and other products with TrackWise Digital. The built-in templates comply with ISO 14971 and ICH Q9 allowing manufacturers to manage risks throughout the entire product lifecycle directly within TrackWise Digital.

  • Quality events are inevitable, no matter how much care is taken to avoid them. As a critical part of a quality management system, CAPA identifies and addresses the root causes of high-risk quality issues and helps to limit the resulting business impact, both immediately and in the future.

  • The Composable MES for Pharmaceuticals provides a starting point for you to implement a tailored, connected production system with end-to-end traceability and right-the-first-time electronic batch records (eBR).