SALT LAKE CITY– February 14, 2008 – MasterControl Inc., a global provider of GxP process management software solutions, today announced the availability of MasterControl™ Version 7.0, which immensely enhances the company’s offerings with the introduction of five new modules.
The release of Version 7.0 is consistent with MasterControl’s commitment to provide a comprehensive GxP process management solution for life sciences industries and other companies doing business in regulatory environments. Version 7.0 builds upon the traditional strengths for which MasterControl is renowned—compliance, connectivity, and ease of use—and extends those characteristics to five new robust GxP process management software applications:
• The enhanced MasterControl Submissions Gateway™ allows companies doing business in regulated GxP environments to maintain control in assembling and tracking documentation vital to submissions. The enhanced Submissions Gateway works with any publishing system—present and future—without requiring custom connectors. The solution allows companies to meet the requirements for good document control within the confines of FDA-regulated environments, including compliance with 21 CFR Part 11.
• MasterControl Submissions Locker™ provides a secure MasterControl environment that is accessible to any publishing tool preferred by the user. The Submissions Locker works in tandem with MasterControl’s enhanced Submissions Gateway to help companies doing business in regulated environments to better prepare and control electronic submissions to regulatory agencies by supporting a full lifecycle for creating submissions. The Submissions Locker streamlines the document assembly and organization process starting at the beginning of the submissions cycle by maintaining up-to-date documents in a secure, centralized repository. By controlling submissions documentation before, during and after the publishing process, MasterControl makes it possible for all departments involved to have increased confidence in the regulatory submission. The Submissions Locker solution is specifically designed to help companies to meet the requirements of GxP industry standards and regulatory guidelines.
• MasterControl BOM™ (Bill of Materials) is a valuable tool for medical device developers and other manufacturing companies that need to integrate the BOM with the document management system, thereby allowing multiple revisions to be approved and used for reference while permitting all departments to have easy viewing of in-process changes. The flexible, easy-to-use BOM solution controls the multiple iterations of a BOM generated during the design process and enables users to exchange BOM data with suppliers, buyers, and planners. MasterControl BOM insures that all departments have an accurate, updated view of the revision levels of every component in their particular configurations.
• MasterControl PDM Connectors facilitate collaboration and redlining on PDF versions of drawings while insuring that the PDF copies in the MasterControl system stay in sync with native files in the PDM solution. MasterControl PDM Connectors link CAD systems with the highest level of document control to create an ideal master management system. The PDM connectors now available from MasterControl interface with the most popular PDM solutions in the industry, including PDMWorks® from SolidWorks and PTC’s Pro/IntraLink® and Windchill®.
• MasterControl Copies™ is a comprehensive product that combines several beneficial features of copying and printing multiple files into a single solution. MasterControl’s Copies solution addresses the challenges faced by companies that have a dire need to copy, print and distribute considerable amounts of documentation. By allowing users to copy many files simultaneously, spool multiple files to a network printer at the same time, and control the output of copied and printed files, MasterControl Copies increases overall efficiency and streamlines GxP processes.
With Version 7.0 MasterControl is aiming to: • Introduce new vital modules and expand current offerings to facilitate compliance management and better address the many needs of diverse customers. • Allow current users to broaden the applicability of their MasterControl systems by adding new enhancements and robust capabilities. • Build upon MasterControl’s strategic “continuous validation” approach, which makes software validation easier, faster, and more cost-efficient for FDA-regulated companies. MasterControl’s integrated compliance software solution allows life sciences companies to meet and exceed strict FDA requirements, but hundreds of companies also use the software for compliance with ISO standards, Sarbanes-Oxley Act, and similar regulations. MasterControl facilitates compliance management by automating and managing document and change control, training management, audits, corrective/preventive action (CAPA), customer complaints, nonconformance disposition, deviation handling, electronic batch record (EBR) management, and other GxP processes critical to regulatory compliance.
About MasterControl Inc. MasterControl Inc. has been at the forefront of providing document management and GxP process solutions to life sciences companies since 1993. Hundreds of companies around the world rely on MasterControl to automate and effectively manage their GxP processes. The MasterControl solution is easy to use, deploy, validate, and maintain. MasterControl incorporates industry best practices for automating and connecting every stage of the product development cycle. By combining an integrated platform with a continuum of risk-based software validation products, implementation services, training and technical support, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. For more information, visit the MasterControl website, or call 800-825-9117.
