September 14, 2006

Show Your True Quality: The Importance of Leveraging an Enterprise-Wide Quality Management System


-- White paper from AssurX, Inc., demonstrates how QMS is the foundation for efficient operations company-wide

-- FDA inspectors zero in on the Quality System Inspection Technique (QSIT) program when they investigate company operations – and the agency holds managers ultimately responsible if it finds anything it doesn’t like

-- Quality companies focus on quality operations to boost the bottom-line and avoid damaging regulatory and public relations nightmares over failed product or human injuries

MORGAN HILL CA USA-- September 14, 2006 -- A new white paper from AssurX helps companies to better understand the true meaning and importance of quality control in all aspects of its operations. The white paper, “Show Your True Quality: The Importance of Leveraging and Enterprise-Wide Quality Management System,” features several real-world examples of how quality systems can benefit or harm a company.

AssurX, the leader in compliance and quality systems, today revealed that leading companies are using enterprise-wide QMS to get their products and services to market faster, more efficiency and safer. But the white paper also reveals that many companies do not have a real handle on why QMS matters or how much it can impact operations. The white paper features several “grim reminders” of companies that have failed to maintain their desired quality standards. It also features mini case-studies from companies that “got it right,” including Fischer Imaging.

As industry experts including former FDA inspectors have stressed, the agency is quite focused on quality systems when it conducts an inspection and considers issuing a warning letter. FDA inspectors expect companies to have solid QMS systems in place that will protect customers and promote product efficacy.

HIGHLIGHTS OF THE WHITE PAPER INCLUDE:

--Insights from quality experts regarding the importance of QMS

-- Why weak quality controls often turn into embarrassing and costly product recalls

-- How some companies are leveraging quality control to not only meet regulators demands but improve operations and boost the bottom-line

--What FDA inspectors are looking for in the Quality System Inspection Technique (QSIT)

-- A resource box featuring key Internet sites and other useful information

REQUEST A COPY OF THIS WHITE PAPER:
To receive your complimentary copy, contact the company directly at 408-778-1376 ext 705.

ABOUT ASSURX, INC.
AssurX, Inc. provides FDA-regulated organizations with enterprise-wide solutions for their quality systems needs. CATSWeb is the proven leader as the industry's enterprise quality software of choice used at FDA-regulated and ISO/QS 9000 certified companies around the world. CATSWeb is a zero client application that can be accessed from any computer, running any operating system, with any Web browser, anywhere and anytime that an Internet or intranet connection is available. CATSWeb is used at FDA regulated companies around the world, including Guidant Corp, Fischer Imaging, Boston Scientific, and Bausch & Lomb. AssurX is headquartered in Morgan Hill CA.