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To improve product quality, manufacturing nonconformance materials and processes must be readily visible, enforceable, easy to analyze, and fully traceable to their origins. A non conformance report that is disjoined from manufacturing can place the company at risk of non-compliance, inefficiency, or worse, a field disaster.
Camstar's Nonconformance Reports and Management system automatically recognizes and reacts to non conformance events such as deviations in processes, materials, events and test results. It enforces structured failure analysis, root cause identification, quarantine and final disposition (release, rework, scrap, etc.).
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From the time the deviation occurs until disposition, manufacturing non conformance reports provide complete electronic traceability and links to root causes. Electronic non conformance reports are created immediately, when the information is most readily available. As a result, non conformance reports provide instant visibility and control of the affected material, and prevent products with open issues from being processed beyond a designated step, issued to or combined with other products, or shipped to finished stock or the customer.
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Camstar Customer Success:
A large Class 3 Medical Device manufacturer reduced its non conformance reports by 80% and improved process yields as a result of deploying Camstar's Manufacturing Execution and Quality System.
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In the life sciences industry, biotechnology
and medical device non conformance disposition that is fully enforced can eliminate risks of non-compliance or product failure. Camstar's Nonconformance Management system seamlessly integrates non conformance reporting and corrective actions,
providing a complete, secure, closed loop system.
Nonconformance Management also includes the analysis processes to assign root cause, and to determine the resolution or disposition of the material. Detailed non conformance report history is included in the complete manufacturing audit trail, and is linked to all affected units, lots or batches.
Nonconformance reports and statuses are visible through online inquiries, and through analysis. Easy access to the manufacturing non conformance data makes problem correlation and analysis fast and effective. Resolutions and non conformance dispositions can be quickly applied to individual units or across an affected set of products.
Learn more about integrated manufacturing non conformance reports and management
for Medical Device manufacturers.
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