ISBN-13: 9783659456176 / Angielski / Miękka / 2013 / 88 str.
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.