The QUMAS Quality Management Solution (QMS) delivers comprehensive regulatory, quality and compliance management, on one platform. This leading solution does not focus solely on the 'process' elements of quality, such as CAPAs, Deviations and Audits, but also ties in the 'content' elements of quality, such as SOPs, documents, and policies. Unlike standard QMS 'point' solutions, the QUMAS QMS creates an integrated environment for all quality activities, ensuring SOPs are updated when impacted by a Deviation or CAPA, all within the one regulatory record. This enables the QUMAS QMS to provide detailed trending and analysis to users, enabling them to identify trends, improve manufacturing processes, and protect ultimately brand integrity.
Manufacturing Improvement - Process deviations can quickly affect bottom-line performance. The QUMAS QMS is designed to help companies adhere with their own standard operating policies and procedures, as well as industry standards and regulations. Since 1994, leading Life Sciences companies have relied on the QUMAS QMS to automate their quality and regulatory processes.
Validated and Certified Approach to Enterprise Compliance Management - QUMAS is the only vendor that provides a complete compliance and validation record across FDA, ISO, DoD, and other global regulations. In addition QUMAS is one of the few vendors in the compliance industry that is ISO 9001:2008 certified, ensuring a structured approach to content, process, and quality management requirements, including:
- SOP Management
- Corrective and Preventive Actions, CAPA solutions
- Customer Complaints
- Deviation Management
- Change Control
- Policy Training and Certification
Webinars - Download the following webinars for more information on the QUMAS QMS:
- Why does your organization need an electronic Quality Management System?
- Best Practice Deviation, CAPA, and Change Control with BIOVIA QMS
- Using SharePoint 2013 as a QMS for Controlled Documents & Quality Processes
- QUMAS Quality Management Solution for Global Regulatory Compliance
- Managing Clinical Deviations and CAPAs in a proven Quality Management System
Benefits - The QUMAS QMS is designed and engineered to deliver real business benefits and low cost of ownership:
- Improved productivity and reduced impact of inspections and downtime.
- Faster approval cycles and reduced rework/recall rates allow you to bring products to market sooner.
- Ability to track actual performance against SOPs, quickly identifying deviations and managing information about them in a single system. A cost effective deviation solution.
- Ability to effectively manage CAPA investigations and conduct root-cause analysis, enabling you to get accurate information and make the right decisions quickly.
- Single data repository makes it easy to track, monitor, trend, and report on performance information.
- Includes a workflow engine, forms manager, fully configurable data dictionary, and business rules engine.
- Easily configurable to integrate into your environment without a heavy IT footprint.
QUMAS Compliance Solution Components