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FCG Enhances Compliance Capabilities of FirstDoc Enterprise Content Management Suite
First Consulting Group, provider of enterprise content management (ECM) for life sciences, announced the addition of robust new functionality and modules to its FirstDoc(R) ECM product suite. These new features represent the latest step in FCG's continued efforts to ensure its clients are more able to respond to landmark regulatory and policy shifts such as Sarbanes-Oxley, the FDA's Structured Product Labeling (SPL), and the EMEA's Exchange of Product Information (PIM).
Increasingly stringent and proliferating regulations in the US and Europe have had a profound affect on life sciences' operations over the last few years. FCG has extensive experience in building and deploying a set of solutions based on its industry-leading content management software suite--FirstDoc(R) Enterprise. FirstDoc Enterprise is designed to better prepare life sciences firms for compliance while helping to synchronize business processes, improve business agility, and create a more responsive IT infrastructure.
By continuing to enhance the robust, proven platform of the FirstDoc Enterprise, FCG enables companies to extend existing compliance functions, such as document audit trails, typically used for GMP and 21 CFR Part 11 compliance, to other areas of their business.
"The increasing emphasis of compliance is to ensure business decision-making is based on accurate information," said Jeff Klein, Vice President of Product Strategy for FCG's life sciences practice. "By taking a more integrated approach to compliance that includes a core content management system like FirstDoc Enterprise, companies can be confident that the information used to support the registration of new and existing products meets the stringent standards placed on industry, potentially preventing a refusal to file, product injunction or withdrawal."
"The FirstDoc Enterprise suite delivers cutting-edge functionality for life sciences, and comprises new and evolving technologies," said Klein. "These capabilities are not found in most base document management repositories currently available to the industry."
New FirstDoc functionality included in FirstDoc Enterprise, version 3.3
The following product enhancements are intended to help companies better comply with regulatory requirements and streamline business processes.
* Ability to create and manage XML components and documents
* Ability to perform dynamic XML content assembly and publishing
* Electronic records management feature that includes automatic calculation of retention dates as well as automatic purging of documents that have expired and that have been confirmed for deletion
* Ability to route multiple documents and/or virtual documents in one workflow operation for review and approval
* Availability of product dictionaries and aliases to all solutions based on FirstDoc Enterprise
New Solutions in the FirstDoc Portfolio
The following new solutions are part of the FirstDoc suite:
1) A global labeling solution that allows companies to comply with new FDA and EMEA requirements for electronic submissions of SPL- and PIM-formatted labeling information from a single source;
2) A contracts management solution for Legal departments that permits companies to manage core aspects of their Sarbanes-Oxley (SOX) compliance by archiving and managing contracts;
3) A tightly integrated, industry-leading, third-party eCTD application with FirstDoc Research & Development, providing a robust submission creation, management and publishing solution. 08.03.2005, First Consulting Group
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