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DataCore Technology
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DataCore’s FDA Module Selected by Large Life Sciences Manufacturers; Momentum Continues

Exton, PA—May 31, 2005--DataCore Technology, a specialist in implementing electronic document management systems, announced the selection of its FDA Module for Cyco AutoManager® Meridian by a global, tier-one pharmaceutical company for use in their numerous facilities world wide. DataCore’s popular FDA module enables organizations to quickly achieve FDA compliance with 21 CFR Part 11. Since the product’s inception in 2002, DataCore has built a distinct portfolio of life sciences manufacturers that have successfully implemented the module to drastically improve compliance effectiveness and reduce residual compliance risk. This has proven to lead to significant cost-savings in the engineering operations of various life sciences companies both in the U.S. and abroad. 

DataCore’s FDA module is targeted at companies in the pharmaceutical, biotech and medical device markets that need to comply with 21 CFR Part 11 and other GMP requirements. The module is an out-of-the-box solution that hooks into the engineering data management engine of Cyco AutoManager Meridian. The combined solution provides a configurable environment with electronic signatures, automatic PDF/DWF renditions, a compliant audit trail, a User Manager with application login, enhanced security measures, and controlled print stamping. 

“Our configurable solution supports FDA and GMP requirements to facilitate the specific needs of our diverse customer base,” says Brian Sallade, President of DataCore Technology. “The momentum for our solutions has been growing. We believe that by providing robust functionality in an out-of-the-box solution, we appeal to a large number of pharmaceutical, biotech and medical device manufacturers.” 

“DataCore has been on the leading edge by providing their expertise in an affordable package,” says Paul Bowman, Marketing Director of Cyco Software. “By offering our combined software solution with their unparalleled knowledge and consulting services, they fulfill the demand in a growing niche market.” 

Numerous life sciences companies have chosen to implement DataCore’s FDA Module with Cyco AutoManager Meridian for a number of reasons, including: 

  • Save time with configurable, out-of-the-box set up

  • Improve efficiency, productivity, and compliance through automation

  • Reduce validation costs with an available GAMP 4 based validation package

  • Enhance collaboration and document control with configurable workflows

  • Leverage engineering documentation by integrating with other enterprise business systems, including MRO MAXIMO, SAP, and Documentum

DataCore Technology has partnered with Cyco Software reseller in the Americas and Europe to offer its FDA module to pharmaceutical companies around the globe. For more information, please visit http://www.data-core.com/pharmaceutical.htm.

About DataCore Technology

DataCore specializes in implementing Electronic Data Management solutions for energy, government, manufacturing, and pharmaceutical organizations to help improve time to market, reduce asset maintenance costs, and comply with government regulations. The company operates with the highest degree of integrity, provides quality products and services, and maintains a steadfast commitment to excellence. For more Information, please visit www.data‑core.com or call (800) 531-2287.

About Cyco Software

Cyco Software provides Engineering Data Management and Application Integration solutions for multiple vertical industries, including manufacturing, energy, government, pharmaceutical, retail and telecommunications. Cyco Software has almost two decades of industry experience with more than 16,000 clients and over 275,000 users in 50+ countries worldwide. The company has offices in the USA, UK, Germany, Italy, Korea, Russia and The Netherlands, and an extensive global network of established partners around the world. Cyco Software ensures a high level of service and support for its leading software solutions Cyco AutoManager Meridian and Cyco AutoManager TeamWork. For more information, please visit www.cyco.com, or call (800) 323-2926 ext 110 (Americas) or +31 (0) 70 413-3700 (Europe).