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Archived news announcement

Cyco Software and DataCore Technology Partner to Introduce FDA Compliant Solution to Manage Engineering Information

Pharmaceutical, Medical Device, Healthcare Manufacturers Are Invited To Join Live Worldwide Webcast on August 8, 3:00 pm EDT


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ATLANTA - July 29, 2002 - /PRNewswire/ -- Cyco Software, a global software leader dedicated to providing industry-focused ERP business process integration and CAD productivity solutions, announced today that it has partnered with DataCore Technology to offer a new FDA compliant add-on to its AutoManager Meridian 2002 business integration software. Unlike many other products available, this solution is unique for its built-in FDA compliance with GMP, 21 CFR Part 11 and Engineering Document Management (EDM) best practices regarding CAD documentation. This will lead to significant cost-savings in the engineering operations of life sciences manufacturers.

Cyco Software and DataCore host a *Live Webcast* on August 8 at 3:00 pm EDT to present the AutoManager Meridian 2002 FDA Module. Pharmaceutical professionals are invited to sign up for the event at http://cyco.webex.com.

For pharmaceutical companies, the need to reduce time-to-market for new products is a challenge due to the strict regulatory environment in which they must operate. With the implementation of an engineering document management system, companies will gain a significant competitive advantage by enabling faster access to key engineering documentation, automated approvals, revision control, and secure workflow processes.

AutoManager Meridian's FDA module has been designed as a configurable add- on, implemented with consulting services, made for rapid and easy deployment to manage GMP controlled engineering documents with pre-configured templates, workflows and lifecycles which drastically improve compliance effectiveness and reduce residual compliance risk.

The FDA module for AutoManager Meridian provides the following:

  • Enhanced access control
  • Configurable event auditing
  • Audit trail compliant with 21 CFR Part 11
  • Electronic signatures compliant with 21 CFR Part 11
  • Pre-configured workflows and additional workflow features
  • Pre-configured document types
  • Enhanced user lifecycle notifications
  • Controlled printing and watermarking
  • Administrative tools
  • Lifecycle documents and procedures as evidence of the development methodology adhered to during development of the FDA module

Eric Bouwer, CEO & President of Cyco Software, says: "This new module for our flagship AutoManager Meridian solution strongly underlines our commitment to offering tailored solutions to emerging document management and business integration needs in a range of market industries." He continues: "DataCore's uncontested expertise and experience in the pharmaceutical market and their commitment to developing this FDA compliant add-on will be extremely valuable to Cyco and our Life Sciences customers worldwide."

"There was an overwhelming market demand for a 21 CFR Part 11 compliant solution focused specifically on managing engineering documents," says Brian Sallade, President with DataCore Technology. He explains: "Engineering documents and their related processes are unique from other document types throughout the enterprise. Often times, companies believe one system can satisfy the needs of everyone, but we have been watching engineering departments within pharmaceutical companies strongly resist the corporate enterprise document management standards because of limited engineering- focused functionality." Sallade concludes: "With the FDA module for AM- Meridian, they can now have the system they really want."

About Cyco Software

Cyco Software provides Engineering Document Management (EDM) and Application Integration solutions for multiple vertical industries, including manufacturing, energy, government, healthcare, retail and telecommunications. Cyco has almost two decades of industry experience with more than 15,000 clients and over 250,000 users in 50+ countries worldwide. The company has offices in the USA, UK, Germany, and The Netherlands and an extensive global network of established partners. Cyco ensures a high level of service and support on a truly worldwide scale for its leading software solutions AutoManager Meridian and AutoManager TeamWork.

http://www.cyco.com

About DataCore Technology

DataCore Technology is a full-service information management and technology consulting firm. DataCore has become a recognized leader in providing document management solutions that include CAD integration for customers in the manufacturing, utilities, and pharmaceutical industries. DataCore operates with the highest degree of integrity, provides quality products and service, and maintains a steadfast commitment to excellence. Its customer base ranges in size -- from small engineering departments with a few users at a single site, to world class customers with hundreds of users located throughout the world.

http://www.data-core.com 

 

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