New MasterControl FDA Software Opens World of Electronic Document Control to FDA Regulated Manufacturers

Business Wire, August 10, 1998

SALT LAKE CITY--(BUSINESS WIRE)--Aug. 10, 1998--Document Control Systems, Inc. announced today a new document control software which opens, for the first time, the world of electronic document control to manufacturers required to meet FDA GMP certification.

6 The new software, called MasterControl(TM) FDA Edition meets the Food and Drug Administration's strict requirements for electronic signatures, effectively eliminating manual document control for food, pharmaceutical, and medical device manufacturers.

MasterControl FDA Edition is a powerful Windows-based client/server application designed to meet the electronic signature and document security requirements of the FDA GMP, including dual signature path for ultra secure electronic document approval, 32-bit password encryption to ensure tight password security, password expiration, intruder lock-out, and account lockout functionality.

MasterControl FDA Edition provides a secure document environment using a simple graphical user interface. Unique in its approach to document control and change management, MasterControl combines powerful time-based routing capabilities with a completely secure document vault system in a scalable, open systems architecture.

In addition, the FDA Edition of MasterControl includes field level change tracking and change rationale tracking which record the date, time, changes, and rationale for the changes made to documents, providing an elegant method of tracing document changes, a feature vital in FDA certification.

In addition to MasterControl's electronic signature capabilities, Document Control Systems also offers a testing program to assist in the FDA validation of MasterControl for use as document control software on the manufacturing floor.

This validation testing program includes on-site testing assistance, and detailed installation test and functional test documents for MasterControl. Document Control's validation assistance program helps manufacturers dramatically reduce the software validation process which can take months to complete to a matter of days.

Product Specifications and Pricing

MasterControl FDA Edition supports major client/server databases such as Oracle, Microsoft SQL Server, InFormix, and Sybase. It is a file format-independent application that lets users view and work with documents created in any word processing, spreadsheet, page layout, or CAD/CAM program.

It supports Novell, Windows NT, DEC Pathworks, and other network operating systems. It requires an Intel 486 processor with a minimum of 8 MBytes RAM operating Windows NT, Windows 95, or Windows 98. Its optional WebControl(TM) Internet module provides multi-platform browser access to controlled documents in MasterControl through any Internet connection.

MasterControl FDA Edition has a base single-user license price of $899 with custom configuration and installation options available to customers as needed. MasterControl FDA Edition is available through authorized VARs, CimWorks GageTalker, and Document Control Systems, 800/825-9117.

For More Information

Editors seeking more information on Document Control Systems, Inc. and its products should contact Suzanne Kimball, Press Relations for Document Control Systems, voice/FAX: 801/294-4779, Internet: suzkimball@aol.com. All other inquiries should be directed to Document Control Systems, 302 West 5400 South, Salt Lake City, Utah 84107, 800/825-9117, 801/281-8366, FAX: 801/281-8375, www.mastercontrol.com.

Founded in 1993, Document Control Systems, Inc., based in Salt Lake City, is a privately held company recognized as a leading developer of document control and change management software used to meet quality standards for ISO/9000 and FDA GMP certification. The company is gaining a reputation for its popular MasterControl(TM) software which combines powerful routing capabilities and ultra-secure document control with a scalable, open systems architecture and non-proprietary relational databases. The company markets its products direct to customers, offering a multi-phase implementation and training plan, and life-long technical support. Document Control Systems has sales offices in Salt Lake City, Chicago, and Detroit, and throughout Europe, Australia, South America, and Mexico.

    CONTACT:  Document Control Systems
               Suzanne Kimball, 801/294-4779 (Press Relations)
               Brad Wright, 801/281-8366 (President)