ICM Corporation’s Leopard v5.0 Simplifies EDMS Deployment, User Experience

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ICM Corporation announced the release of Leopard™v5.0, the new version of the software developer’s innovative Electronic Documentation Management System (EDMS) solution for FDA-regulated companies. Leopard v5.0 is one of a suite of ICM products that combine to deliver comprehensive compliance management and fully automate the documentation life cycle for pharmaceutical, biotechnology and medical device companies.

Version 5.0 simplifies what is already the industry’s least complex and most efficient system for document management. The release’s new features include dynamic menus which reduce user decision-making and an enhanced XML-based workflow engine which automates many business process tasks. These enhancements deliver dramatically improved productivity and reduced deployment and training time and costs.

Leopard v5.0 is seamlessly integrated with Microsoft™ Office applications, allowing users to communicate with the EDMS environment directly from any Office application without the need for client-side software, speeding user acceptance and relieving IT staff from the burdens of maintaining and supporting client side “plug-ins” to applications.

Other Leopard v5.0 enhancements include an updated template manager that allows users to create numerous types of official documents, such as Standard Operating Procedures, while ensuring conformity and compliance with published corporate and FDA guidelines. Leopard v5.0’s security authorization module can optionally be configured without input from a network administrator to control user access and define user roles for each type of document in a company’s workflow.

Leopard v5.0 embodies all the features you would expect from an advanced document management system: version control, check in/out, reversible document history. More than meet expectations, Leopard v5.0:

* ensures documents meet quality control standards.

* ensures documents, such as SOPs, are uniform by default.

* manages corporate graphics, so that when a change is made in one place – a logo is revised, a document format is changed, etc. – it is automatically available to, all system users.

* provides a comprehensive audit trail about documents in the system, so system administrators can provide extensive reporting about the document and its life cycle.

Leopard v5.0 helps FDA-regulated companies adhere to CFR Part 11 regulations. Users sign documents and convert them into Adobe PDF format as a single process. Signing and PDF conversions are performed on the server, eliminating the need to use “printer drivers” to create PDFs. Signatures are time- and date-stamped on the server, avoiding risks associated with local PC clocks. Once signed, the signatures are stored with the final official document.

The server supports many document types, including regulated and non-regulated business documents. Leopard v5.0 is multi-nodal and can provide a secure official document store as well as a general document store on a single server.

02.02.2005, ICM Corporation




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