Document Management System

Customer

Stelex — a provider of enterprise-wide compliance solutions to regulated industries in the Pharmaceutical, Medical Device, Diagnostic and Biotechnology sectors. For this project Sunbay was a sub-contractor while Stelex was a direct contractor for the world's most comprehensive and broadly based manufacturer of health care products headquartered in New Jersey, USA.

Challenge

The challenge of the project was to automate the drug documentation lifecycle. Each stage of the drug lifecycle requires producing multiple documents describing various aspects of each activity. The lifecycle of any document follows rules and standards of the drug producing company that, in turn, is regulated by the federal agency FDA (Food and Drug Administration). These rules and standards of a document lifecycle could be expressed in concepts of document types, templates, document metadata, and document workflow associated with the document type in relation to the company structure.

Very rough estimation of the total number of the document circulating in the system gives the number of one million. Assuming that one document is associated with 10-15 metadata attributes we came up with the number of 13 millions metadata attributes coexisting in the system.

Multiple Documentum systems do no go well with each other by numerous reasons. The major one is the different metadata structure that prevents two Documentum systems to be merged together. The process of the metadata standardization across the whole company is too complicated. In addition, Documentum is not the only system used for document management. Some systems have conceptually different metadata structure to prevent their easy integration.

It causes manual synchronization between multiple document management systems that leads to errors and slow processing.

So the desired software was required to be able to integrate multiple document management systems of different types.

Solution

In 6 months Sunbay has developed a solution allowing cross system operations like workflow between various systems, document search, and publishing. The system was called Newton.

Newton keeps all documents in the specific document management systems. To interoperate with other document management systems, brokers (like Venetica VeniceBridge) are used.

The solution maintains the unified folder/document structure with pointers to the specific systems folders and documents. It’s important as different document management systems use different folder/document structures (windows uses drive letters, Unix — root file system while Mac utilizes folders separated by colon).

Newton also maintains the unified document metadata structure. It automatically synchronizes the actual metadata with the specific structured metadata of each document management system. This feature makes document search using metadata possible. Keep in mind that different document management systems use different metadata structures. Some do not have them at all (like file system). In this case metadata might be entered directly into Newton.

The software supports its own workflow management that allow to define document lifecycle across multiple document management systems. A workflow includes reviewing and approval cycles as well as custom actions defined by the system administrators.

Metadata structure as well as metadata and workflow for each document type can be defined by the system administrators without programming intervention.

Providing simple and rich user interface, Newton was an automatic solution for the problems users used to resolve manually. It allows defining flexible workflows, metadata, and integrating multiple document management systems.