News - New MasterControl Version 8.1 QEM Offerings

MasterControl Announces Availability of New Quality Event Management Solutions

SALT LAKE CITY, UT, USA – December 7, 2009 – MasterControl Inc. a global provider of software solutions that enable regulated companies to get products to market faster while reducing overall costs and increasing internal efficiency, today announced the release of MasterControl version 8.1.0, which includes new, unsurpassed quality event management (QEM) offerings.

"MasterControl offers polished solutions that can fit any organization, even the largest life sciences companies," said Ken Petersen, MasterControl Product Manager / Quality Management Architect. "Whether all inputs are run through a QEM system that acts as a 'command central' or if data is entered directly through specific entry points of a channel management system, MasterControl has a corresponding QEM solution that can harmonize with and enhance any quality management system processes."

MasterControl offers three separate solutions designed to meet the exact QEM and corrective and preventive action (CAPA) needs of any organization. Each solution has been carefully constructed to bring maximum performance balanced with paying the right price for the right package. MasterControl's QEM solution packages have been reviewed and refined by industry groups to insure that they meet the highest standards and best practice processes. The new offerings include:

  • QEM Ready Set™ is designed to be used by small, growing companies right out of the box.
  • QEM Tailor Fit™ is for companies that need more robust functionality to manage multiple input sources and provide the additional controls required by midsize to large companies. QEM Tailor Fit is highly configurable and has unique Intelligent Forms™ that act as a virtual consultant that guides users through important processes, such as investigation and risk assessment.
  • QMS Total Advantage™ is the most robust system package that ties all aspects of Document Management, Supplier Management, Training Management, and Quality Event Management to form a company's complete quality management system (QMS).

Each MasterControl Quality Solution is designed to automate and effectively manage the CAPA process and integrate it with other quality processes, such as change control and customer complaints. MasterControl uses a foundation of excellence in Controls, Processes, and Competency as underlying core principles to guarantee that the solution implemented will provide the compliance results the organization demands and the methods and skills to succeed. Each of these elements is carefully examined during the initial assessment and built into the early stage business report reviewed with management.

The intelligent MasterControl Tailor Fit solution guides users through the CAPA process with the assistance of embedded coaching questions. The product includes a best-of-breed CAPA methodology and comes complete with initial assessment (business plan), best practices training, and consulting. MasterControl has teamed with PathWise Inc., an innovator in the development of compliance training programs. Each MasterControl QEM and QMS solution includes specifically tailored PathWise training for organizations that need to integrate software solutions in order to build competency as a part of core success strategy.

All MasterControl QEM or QMS solutions are built upon the best software platform in the industry. MasterControl's integrated software solutions are expressly designed to help life sciences and other manufacturing companies meet and exceed stringent regulatory guidelines such as FDA requirements and ISO quality standards.

About MasterControl Inc.
MasterControl produces software solutions that enable companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit, or call: 800-825-9117 (U.S.); +44 1256 325 949 (Europe); or 03-6801-6147 (Japan).