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By Master Control
Introduction
“Can we all get along?” This was the line made famous by Rodney King, the African-American taxi driver beaten by Los Angeles police officers, in his appeal for calm during the 1992 Los Angeles riots. The violence broke out after the acquittal of four officers charged with using excessive force when they stopped King for speeding. The riots lasted six days, causing nearly $1 billion in financial losses. While lack of cooperation between product development engineers and quality professionals in medical device firms doesn’t cause nearly as much damage as the L.A. riots, it does cost their firms untold delays and inefficiencies that can translate into millions of dollars during the course of product development.
Product development (PD) professionals, especially engineers, are the innovators in medical device firms and the driving force behind new products. Their overriding goal is to gain competitive advantage by getting to market as soon as possible. On the other hand, quality professionals are responsible for compliance with U.S. Food and Drug Administration (FDA) requirements, as well as with other regulations and quality standards. Sometimes compliance gets in the way of a timely product launch. Oftentimes the product development team equates the role of the quality group as that of a “policeman”; it considers compliance in general as just another obstacle on the arduous road to product
The mission of PD engineers is seemingly at odds with the goal of quality professionals but is discord inevitable? This white paper will show you that the answer is no. Cooperation between the two camps is not only necessary but possible. This white paper will show you how the MasterControl™ GxP process and document management software solution can facilitate collaboration between product development and quality teams, and among various teams within the firm.
 Click Here to read the complete Whitepaper...
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