FCG Completes Implementation of Organon’s Electronic Document Management System - InformationWeek

InformationWeek is part of the Informa Tech Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them.Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

IoT
IoT
Government // Enterprise Architecture

FCG Completes Implementation of Organon’s Electronic Document Management System

FCG's FirstDoc R&D solution will ensure regulatory compliance and create a secure document repository for users in the US, Japan, and the Netherlands.

First Consulting Group, Inc., an industry leader in enterprise content management (ECM) for life sciences, announced today it completed the implementation of its FirstDoc Research & Development (R&D) solution at Organon, a global leader in the creation of innovative prescription medicines for gynecology, mental health and anesthesia. FirstDoc is now helping Organon manage electronic documents across its R&D operations. FCG will also provide ongoing consulting and maintenance services for the company's electronic document management system (EDMS) that now supports more than 2,000 users in Oss, Netherlands; Roseland, New Jersey; and Osaka, Japan.

The EDMS project delivers three specific benefits at Organon: a secure repository for authoring, importing, editing, maintaining and archiving documents; a validated global EDMS, which is compliant with GxP regulations; and reassurance that projects will remain compliant with legal and regulatory requirements globally.

“We chose FCG for our EDMS needs because we wanted a partner who offered a proven, regulatory-compliant EDMS technical platform, and possessed strong project management and communication skills as well as an in-depth understanding of drug development processes," said Hein Xhofleer, IT Project Manager at Organon. "FCG delivered on its promise to implement in a timely, efficient manner, and ultimately lowered our total cost of ownership by providing us with a product that is easily configurable to our needs".

"Organon’s implementation is an excellent example of deriving business benefit enabled through best practices and technology. FCG is very pleased that Oganon has recognized real business benefits by deploying the FirstDoc solution,” said Jeff Klein, Vice President in FCG's Life Sciences practice.

FirstDoc provides a document management solution to support the R&D and regulatory submission process. The solution includes a content organizational design that reflects current ICH guidelines and easily facilitates a CTD/eCTD submission through tight integration with industry-leading publishing tools. FCG also has developed additional configuration sets to FirstDoc R&D that address requirements for submission of electronic labeling information in XML to the FDA in the US and the EMEA in Europe.

FirstDoc R&D is a single application in FCG's FirstDoc Enterprise suite, which also includes solutions for clinical trials, marketing and sales, manufacturing, and medical communications, as well as corporate functions such as legal and human resources. The FirstDoc suite is compliant with 21 CFR Part 11 and has been implemented at more than 40 life sciences organizations around the world. With consulting, technology, outsourcing, and software products, FCG's Life Sciences practice helps companies comply with regulations, reduce costs, improve business processes, increase customer satisfaction, and bring products to market faster.

We welcome your comments on this topic on our social media channels, or [contact us directly] with questions about the site.
Comment  | 
Print  | 
More Insights
Commentary
Get Your Enterprise Ready for 5G
Mary E. Shacklett, Mary E. Shacklett,  1/14/2020
Commentary
Modern App Dev: An Enterprise Guide
Cathleen Gagne, Managing Editor, InformationWeek,  1/5/2020
Slideshows
9 Ways to Improve IT and Operational Efficiencies in 2020
Cynthia Harvey, Freelance Journalist, InformationWeek,  1/2/2020
White Papers
Register for InformationWeek Newsletters
Video
Current Issue
The Cloud Gets Ready for the 20's
This IT Trend Report explores how cloud computing is being shaped for the next phase in its maturation. It will help enterprise IT decision makers and business leaders understand some of the key trends reflected emerging cloud concepts and technologies, and in enterprise cloud usage patterns. Get it today!
Slideshows
Flash Poll