Addon covers FDA rules
A
BlueCielo ECM Solutions product story
Edited by the Engineeringtalk editorial team
Jul 31, 2002
Cyco Software has joined with DataCore Technology to offer a new FDA compliant addon to its AutoManager Meridian 2002 business integration software.
Cyco Software has joined with DataCore Technology to offer a new FDA compliant addon 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.
The two companies are to host a live webcast on 8th August at 3:00pm 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.
Eric Bouwer, CEO and 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".
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