Process Signatures
In a heavily-regulated industry where the quality of products is imperative because human lives are at stake, medical device manufacturers using Sciemetric’s in-process testing methods have at their disposal highly-detailed compliance records and device history records that provide complete visibility into manufacturing processes and make compliance much easier to prove. Process signature technology delivers the best in-process determination of process health and part quality as well as providing data for post-production analysis
But don’t just take our word for it.
In both its Process Analytical Technology, or PAT, quality framework for pharmaceutical manufacturers and Title 21 CFR Part 820, the U.S. Food and Drug Administration highlights process signatures or electronic signatures as effective tools for monitoring critical manufacturing processes and improving quality.
Click here to download the white paper to get the full story on how PAT can directly improve quality and efficiency in medical device manufacturing.
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