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Quality Digest

FDA Compliance

Signature Verification System for Medical Manufacturing

Published: Tuesday, November 27, 2007 - 23:00

(Sciemetric Instruments: Ottawa, Canada) -- Sciemetric Instruments has announced the general availability of SigPOD Medical, a system to verify parts and processes in the manufacturing of medical devices.

Regulatory initiatives such as the Food and Drug Administration’s Process Analytical Technology and the Global Harmonization Task Force, are driving medical device manufactures to reduce risk in production processes and apply in-process verification. These manufacturers are also shifting to increasing volume and decreasing margins and moving from batch to single-part flow systems. These factors lead to the need for automated, in-process verification and the ability to maintain traceability records on production activities.

“Medical device manufacturers are looking to gain from the experience of high volume, high complexity manufacturing environments for tools and techniques to assist in controlling product and process variability,” says Nathan Sheaff, founder of Sciemetric.

SigPOD Medical is designed for usability and visibility in the live production environment, and offers a full range of instrumentation for verifying and controlling a variety of standard manufacturing operations. It is CFR 21 Part 11 security compatible, and features serialization support and validation documentation.

Traceability and detailed analysis, through SigPOD Medical companion product and database QualityWorX software, enables medical device manufacturers to conduct true multi-variable analysis based on real-world sources of variation in manufacturing, develop standards for monitoring and improvement, and adjust processes to meet quality and volume objectives, all utilizing data collected in-process.

SigPOD Medical monitors physical parameters during manufacturing processes such as press assembly, crimping and swaging, corona and plasma monitoring, adhesive dispensing, injection molding, and many more. It applies the science of process signature verification to provide a detailed analysis of the health of the process, and indicates pass/fail in real time on the production line.

For more information, visit www.sciemetric.com/news_details.asp?nid=63

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