News

Sage Submissions Templates Now Available from MasterControl

SALT LAKE CITY– December 5, 2007– MasterControl Inc. today announced the availability of Sage submissions templates directly from MasterControl. Sage Templates™, a product of Sage Submissions, LLC, provide a standardized platform for authoring documents for the pharmaceutical and biotech industries.

“By combining MasterControl solutions with Sage Templates customers will be able to focus on creating submissions content rather than wasting time formatting submissions documents,” said Michael Bothe, MasterControl vice president of business development. “Sage Templates are derived from real world lessons learned from real world submissions. Uniting these products brings MasterControl customers the most comprehensive set of submissions solutions imaginable.”

The MasterControl solution suite is designed to automate and effectively manage document control, change control, audits, corrective and preventive actions (CAPA), regulatory training, nonconformance, customer complaints, and similar GxP processes. MasterControl’s flexible, user-friendly software solutions provide continuous compliance with regulations such as FDA guidelines, ISO standards, and the Sarbanes-Oxley Act.

With Sage Templates, MasterControl users can write standard submission documents once and submit them many times to regulatory authorities around the world who subscribe to the Common Technical Document (CTD) format for paper and electronic submissions. Sage Templates facilitate compliance with International Conference on Harmonization (ICH) and U.S. Food and Drug Administration (FDA) guidances for the format and appearance of documents intended for regulatory submissions. Available in a wide range of document types—from IND to eCTD and specific regulatory documents—Sage Templates provide a common starting point and consistent formatting.

Sage Templates use Microsoft Word styles that can be easily customized to match corporate styles and standards. All templates come with macro-free, customized toolbars for applying standard format and allowing integration into more strictly secured information technology infrastructures. Using Sage Templates to create documents allows authors to use consistent formatting and structure so each component can be brought together seamlessly into a single PDF document. Sage Templates preformatted styles allow users to easily create tables of contents, automatic bookmarks, and consistent hyperlinking structures in and between documents – saving users time and ensuring consistency.

About Sage Submissions, LLC
Sage Submissions provides consulting services, products and expertise to help companies transition into the electronic submission environment and improve upon existing processes to reduce submission preparation time and facilitate compliance. Sage Submissions’ lead template designer has extensive experience with industry standard electronic document management systems and publishing tools such as Lorenz’s docuBridge.

About MasterControl Inc.

MasterControl Inc. is a worldwide leader in providing GxP process and document management software solutions for life science companies. The MasterControl solution is easy to use, easy to deploy, easy to validate, and easy to maintain. MasterControl facilitates regulatory compliance and incorporates industry best practices for automating and connecting every stage of the product development cycle. MasterControl drives down total ownership cost and enables customers to extend their investment across the enterprise by combining an integrated platform with a continuum of risk-based software validation products and services. Since 1993 hundreds of companies around the world have relied on MasterControl for easier compliance, faster validation, and better process management. For more information, visit the MasterControl website or call toll free at 800-825-9117.