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.