As the leader in providing integrated quality management software systems to companies all around the world, MasterControl is making news and leading the way in solving business problems for all types of regulated manufacturers.
SALT LAKE CITY, UT, USA - February 4, 2008 - MasterControl Inc., a leading global provider of GxP process management software solutions, today announced that it will exhibit the new MasterControl Submissions Locker™ and the enhanced MasterControl Submissions Gateway™ solutions at the Drug Information Association (DIA) Conference for Electronic Document Management, being held February 5-8, 2008 in Philadelphia, PA. Attendees of the 21st Annual DIA Conference will be able to visit booth #102 to see how MasterControl provides greater security for and control over submissions documentation.
The two MasterControl submissions solutions are modules of the recently released MasterControl Version 7.0, which builds upon the traditional strengths MasterControl is renowned for-compliance, connectivity, and ease of use-and extends those characteristics to the new robust GxP process management software applications.
"Working in tandem with the MasterControl Submissions Gateway, 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," said Lane Hirning, MasterControl product manager, pharmaceutical industry expert. "The MasterControl Submissions solutions insure that regulatory users are always working with the most current version of a document. By controlling submissions documents before, during and after the publishing process, MasterControl's Submissions Gateway and Submissions Locker solutions give all departments increased confidence in the regulatory submission."
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 Submissions Gateway 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 jointly 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. The Submissions Locker solution is specifically designed to help companies meet the requirements of GxP industry standards and regulatory guidelines. The Submissions solutions available from MasterControl control submissions documentation before, during and after the publishing process.
About MasterControl Inc.
MasterControl is a global provider of document management and GxP process solutions. MasterControl automates and effectively manages document control, change control, audits, corrective/preventive actions (CAPA), regulatory training, nonconformance disposition, customer complaints, and other GxP processes. The MasterControl solution is easy to use, easy to deploy, easy to validate, and easy to maintain. MasterControl incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance with requirements such as ISO standards and FDA regulations. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl reduces the total cost of ownership and enables customers to extend their investment across the enterprise. For more information, visit the MasterControl website or call toll free at 800-825-9117.
The Drug Information Association (DIA) is a professional association of more than 18,000 members worldwide who are involved in the discovery, development, regulation, surveillance, or marketing of pharmaceuticals or related products. DIA is a nonprofit, multidisciplinary, neutral forum for sharing information that optimizes the process of drug development and lifecycle management by providing:
DIA is the universally respected forum for quality information exchange leading to better medicines that enhance health and well-being.