Quality-related recalls in the Life Sciences industry continue to make headlines. As a result, manufacturers face increasing pressure to comply with a growing set of regulations(21 CFR Part 820, CFR Part 11 and ISO 13485). Life Sciences manufacturers are striving to improve quality while at the same time lowering the cost of compliance. The difficult task of taking feedback from a customer complaint, translating it into a design requirement, and executing the manufacturing plan that will provide a competitive edge represents an ongoing challenge. Fragmented IT architectures to solve the different aspects of quality management have resulted in a dramatic increase in TCO while not addressing fundamental regulatory concerns. Solution
Applied Medic eQMS™ for Life Sciences, is tailored to meet the quality, regulatory and business needs of life sciences organizations. As an integral part of the Medic solutions suite, Medic eQMS provides a closed loop, end-to-end solution that helps companies control documents, manage Complaints and product recalls, Exceptions, CAPAs, Root Cause Analysis process, Audits, Suppliers, and Training records. Medic eQMS inherently integrates with other Applied Materials Pillars to drive greater efficiencies, reduce costs, improve quality and deliver profit to organizations.
These capabilities lead to significant improvements in the manufacturing process including: - Improved product quality
- Faster time to market
- Improved compliance management
- Increased operating margins
- Enhanced overall operational performance
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"Even if you opt to start with a narrow compliance system like CAPA tracking, make sure the vendor can expand to automate quality-related business processes, such as incoming and in-line inspections and material disposition, or integrate closely with your Enterprise Resource Planning (ERP) system or Manufacturing Execution System (MES) to make the process seamless for employees." - Bill Swanton
AMR Research
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