Quality Management Solutions
Ensuring Quality and Compliance
QUMAS software solutions help manufacturing organizations analyze performance over time, enabling them to identify trends, improve their manufacturing processes, and protect their brand integrity. Deviations can be quickly and accurately identified and fixed, and information gained can be reported on and stored in a single location so such deviations can be prevented in the future.
Manufacturing Improvement
Process deviations can quickly affect bottom-line performance. QUMAS software solutions are designed to help companies comply with standard operating policies and procedures, as well as industry standards and regulations. More than 80 life sciences companies rely on QUMAS to automate their quality and regulatory processes, including seven of the top 10 pharmaceuticals, and four of the top 10 biotechs.
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 9001:2000 certified ensuring a structured approach to content, process and quality management requirements including:
- SOP Management
- Corrective and Preventive Actions
- Customer Complaints
- Deviations
- Change Control
- Policy Training and Certification
Benefits
- 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.
- 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.
- Low total cost of ownership because it's fully and easily configurable, fully validated, scalable, and easy to use.