BRADENTON, Fla., Oct. 28, 2003 (PRIMEZONE) -- Decision Management International, Inc. (DMI) and CIMA Labs Inc. (Nasdaq:CIMA) have completed the validation and commissioning of the Web-based Regulus(tm) Document Control and Archiving (DCA) software application at CIMA's Eden Prairie, MN, manufacturing facility and its Brooklyn Park Research & Development center. The Regulus(tm) DCA software application is an electronic document management system that facilitates the cGXP document lifecycle using 21 CFR Part 11 controls. The system supports CIMA's initiatives to reduce product time-to-market.
Regulus(tm) DCA provides Web-based access to all controlled documents and supports an electronic change control workflow for document review and approval. "The Regulus(tm) DCA software has resulted in a 40 percent reduction in time spent searching and reviewing cGXP controlled documents," said Jackie Torfin, Director of Quality Assurance and Project Sponsor.
In addition, CIMA was facing an FDA Pre-Approval Inspection and wanted to have the new system production-ready in time for FDA review. "We were very pleased with the reduced time it took to install, train, validate, and commission this initial Regulus(tm) application from DMI," said Adrienne Bodor, Director of Information Technology for CIMA. Regulus(tm) DCA is the first of several Regulus applications purchased by CIMA to address the explosive growth in business sales volume the company is experiencing.
The `off the shelf,' configurable, Web-designed application enabled CIMA to quickly deploy the system for use by 275 production operations staff members in different functional areas prior to the FDA inspection. Regulus(tm) DCA provides the foundation for the installation of additional "zero client," Regulus(tm) software applications that address cGXP requirements for data collection, reporting and control of production order material components, equipment and training records as well as manufacturing batch records and work instructions.
"CIMA's use of the Regulus(tm) DCA software is the first phase of a plan to significantly reduce paper and manual processes in our contract manufacturing operations," reports Don Peer, CIMA project manager for the DCA implementation. "We selected Regulus(tm) because of the reduced cost of validation and configuration time, since all functionality was put in `out of the box,' without custom programming."
In addition, CIMA experienced first-hand the advantages of a zero client, browser-based application: "We completed the installation, training, validation, and commissioning of the computer system and software in 117 days and within the original project budget," Don Peer went on to say.
"Ever-increasing regulatory compliance record keeping and document control demands, coupled with the costs and inefficiencies of paper-based, manual systems, have lead to a significant focus on the cost and time saving benefits that automated, computerized applications can bring to pharmaceutical and biopharmaceutical manufacturing operations," said Frank Grywalski, chairman and CEO of Decision Management International. "We are delighted with the results that CIMA has achieved in such a short period of time."
ABOUT DECISION MANAGEMENT INTERNATIONAL
Founded in 1993, Decision Management International Inc. (DMI) is a leading provider of process manufacturing operational solutions for the FDA-regulated industries. Built on industry standard, open technology platforms using Microsoft .NET architecture, DMI's Regulus(tm) software application suite and services are used by many of the world's leading pharmaceutical, biotechnology and medical device companies. DMI provides the market and its customers with integrated, efficient and cost-effective Web-designed software, configuration, and implementation services to relieve time, avoid cost, and manage compliance risk in cGxP operations. For more information, please visit www.dmius.com.