FirstDoc 3.3 now makes it easier to reuse content by leveraging XML, a programming language known for its flexibility and interoperability. With new organizational mandates around speeding submissions, reducing time to market, and cutting costs, the life sciences industry is moving to a new model for measuring content management effectiveness. New metrics focus on the reuse of content, rather than traditional measurement techniques that focused on time considerations, man hours and productivity. FCG’s incorporation of XML into the new version of FirstDoc reflects the industry’s more sophisticated needs.
“Industry data reveals that life sciences firms can substantially reduce the development time for products if they can reuse content rather than duplicate efforts,” said Jeffrey Klein, Vice President of Product Strategy for FCG’s life sciences practice. “For example, we estimate that companies can reduce the cost of product content development by at least 20 percent based on reuse of common content and safety regulations among products.”
FirstDoc 3.3’s XML capabilities enable life sciences organizations to move away from formatting documents manually and reduce the time and effort required to format content for other media types. FirstDoc 3.3 also streamlines documentation updates while ensuring all of the content remains accurate. The expected result is the ability to bring products to market faster and less expensively.
New regulatory standards set by the FDA and European Medicines Evaluation Agency (EMEA) are also driving the industry’s interest in content reuse and XML. FirstDoc 3.3 empowers life sciences organizations to produce and handle labeling submissions compliant with the latest FDA and EMEA formats, Structured Product Labeling (SPL) and Exchange of Product Information (PIM), respectively. FirstDoc 3.3 also provides a range of document types at the level of granularity required by the most recent electronic Common Technical Document (eCTD) guidelines set by the International Conference on Harmonization (ICH).
“Regulatory agencies have already mandated XML-enabled standards for labeling submissions, and similar standards for other types of submissions will likely follow,” said Klein.
FirstDoc 3.3’s re-architected enterprise object model enables users to share information between vertical applications more easily. By sharing information across vertical applications, companies can make certain they are not duplicating processes between business units and ensure all content is consistent and compliant with changing global regulatory requirements. FirstDoc 3.3 also provides utilities that automate the migration of object definitions within existing FirstDoc installations to the new model, enabling FirstDoc to be rolled out across functional areas according to specific business problems.
FirstDoc is the only content management platform in the life sciences industry that offers full enterprise functionality in an out-of-the-box, regulatory compliant solution. FirstDoc offers a robust and flexible architecture that forms the foundation layer for a full suite of modules.
Further validating the design, performance and scalability of the solution, FirstDoc has met the highest level of certification standards set by EMC Documentum, earning the Designed for Documentum designation. The Designed for Documentum accreditation is for products that meet stringent application design and integration standards for offerings developed on the EMC Documentum ECM platform.
Routing of Multiple Documents
FirstDoc 3.3 provides the capability to route multiple documents and virtual documents in a workflow. Using the FirstDoc 3.3 workflow from either the desktop client or the Web client, users can select a series of documents and route them for review or approval. After successful completion of the workflow, all documents explicitly included in the workflow, or implicitly included via a virtual document, will be transitioned to the appropriate status en masse.
Electronic Records Management (ERM)
Optional with FirstDoc 3.3, ERM includes automatic calculation of retention dates for all documents. Users can extend the retention of individual documents and place groups of documents on “hold”. This is valuable when products are involved in any kind of litigation, for example. ERM includes an optional notification as the retention date approaches, an optional confirmation that expired documents should be deleted and the automatic purging of documents that have been confirmed for deletion.
FirstDoc R&D and FirstDoc Clinical Trials use product dictionaries that manage property information relating to drug products as well as product-specific, non-clinical, clinical, quality and regulatory information. These dictionaries reduce redundancies by being configured for specific documents in order that users do not have to enter similar property information on related documents. FirstDoc 3.3 moves these dictionaries from the application layer into FirstDoc, meaning dictionary access is uniform across FirstDoc applications.
FCG is a leading provider of outsourcing, consulting and systems integration for healthcare, pharmaceutical, and other life sciences organizations throughout North America, Europe and Asia. Through combinations of onsite, offsite and offshore outsourced services, FCG provides low cost, high quality offerings to improve its client’s performance. The firm’s consulting and integration services increase clients’ operations effectiveness with and through information technology, resulting in reduced costs, improved customer service, enhanced quality of patient care, and more rapid introduction of new pharmaceutical compounds.