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  • Broschiertes Buch

This book comprises of various steps involved in finding apt real time SPC software that can replace existing legacy system in a Contract Medical Device Manufacturing Company. After evaluating gaps several software's were considered to fill those gaps and be robust enough to aid several other Quality system requirements.This gap analysis resulted in narrowing down a robust software which can meet current requirements and is flexible enough to accommodate future requirements. This software is them implemented in various phases and validated per FDA requirements.

Produktbeschreibung
This book comprises of various steps involved in finding apt real time SPC software that can replace existing legacy system in a Contract Medical Device Manufacturing Company. After evaluating gaps several software's were considered to fill those gaps and be robust enough to aid several other Quality system requirements.This gap analysis resulted in narrowing down a robust software which can meet current requirements and is flexible enough to accommodate future requirements. This software is them implemented in various phases and validated per FDA requirements.
Autorenporträt
With Engineering management education from st Cloud state university and experience in manufacturing industry pertaining to Quality and Lean systems. Implementing and validating SPC software was my first project at a Medical Device Company. This project was submitted as part of my thesis requirement for graduation to the university.