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Superior Quality Assurance for Medical Device Manufacturing
Process Signature Verification™ provides the most detailed monitoring of your process possible. Science-level analysis is brought directly into the medical device manufacturing plant and leads to the following benefits:
 | Objective proof of process compliance with specifications |
| 100% verification of your medical device against known failure modes |
| Reduced recalls through post-shipment reanalysis |
| Reduced validation times |
| Parametric release for reduced visual inspections |
What is Process Signature Verification™ ?
Process Signature Verification™ uses the change of physical parameters during a (manufacturing) process, to indicate the success or failure of that process, resulting in a 100% quality verification. In addition, Process Signature Verification also produces 100% process documentation and a parametric guide to root cause determination.
A process signature is a detailed description of the behavior of the physical parameters of a manufacturing process, such as force and distance in an assembly press operation.
Features of Sciemetric Process Signature Verification
| High Speed data collection (up to 60 kHz pe channel) |
| High resolution data |
| High repeatability and reproducibility |
| Algorithm development Toolbox with science-level math and reporting facilities |
| In-line algorithm-based signature verification on manufacturing systems |
Download the new datasheet on Sciemetric's Process Signature Verification for medical devices.
Where can you use Process Signature Verification?
Many medical device manufacturing processes and quality tests can benefit from the insight generated by Sciemetric. The physical variables it measures and the calculated values it produces provide detailed information into the manufacturing processes. For instance, calculated ‘work done’ is often used to shorten verification time in press operations.
Who is using Sciemetric now?
Sciemetric Instruments Inc. first provided signature analysis and verification products to the academic world in 1981. The industrial use of the technology was perfected in the automotive industry in the early 1990's. Since then, Sciemetric's scientific analysis instruments have evolved into highly scalable and robust industrial products that serve test and verification requirements on live automotive assembly line around the world and provide superior manufacturing quality control for a wide range of industrial manufacturing processes.
Click here to see a list of some of Sciemetric's customers
Results of Signature Verification
| Reduced Warranty and Recall |
Sciemetric reduced a powertrain recall from 10,000 to 7 units through post-shipment analysis of the signature data.
| Increase Yield |
Sciemetric's technology reduced failures on vacuum pump manufacturing by 98% (savings of $4.8 million a year) by identifying 2 different failure behaviors, one of which could be handled by new specifications on an internal part.
| Accelerated Line Launch |
Accelerated launch by 400% for global automotive company due to insight into process
| Accelerated Process Validation |
Assembly process validation accelerated through signature curve documentation
SCIEMETRIC ARTICLES
| Datasheet for Process Signature Verification solution for medical device manufacturers. Features detailed info on SigPOD Medical and the Quality Analyst Workstation.
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| One-page overview on Process Signature Verification for Medical Device manufacturing.
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White paper: Process Signature Verification - Monitoring for Medical Device Manufacturing
This Sciemetric exclusive paper explains the well-accepted method of Signature Analysis and its growing relevance to fulfilling medical device manufacturing regulations.
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| NEW! Presentation on Process Signature Verification provides excellent introduction to PSV.
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Whitepaper on Signature Analysis
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Quality Management Systems - Process Validation Guidance
Endorsed by The Global Harmonization Task Force, Edition 2, January 2004
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Guidance for Industry
PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
U.S. Department of Health and Human Services Food and Drug Administration, September 2004
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