Our client, a leading provider of oncology and medical imaging read services for global clinical trials, was faced with a number of challenges during a period of rapid expansion.  A key business need was the adoption of a configurable framework for implementing GxP-compliant controlled content solution. The system was required for the management of documents related to their clinical and organizational operational procedures, as well as the protocol specific charters and project documents.  During its initial years, the organization, as many others, created manually intensive processes to manage its controlled documents.  Over time, due to organizational growth and increased volumes, these processes evolved and became more complex and less manageable. In addition, effective controlled documents were made available to consumers through a shared file server resulting in security and compliance concerns.

In order to improve process efficiencies and standardization for the creation, updating, review, approval, and publishing of controlled documents, as well achieve higher levels of compliance, the client sought to implement a Controlled Document Management Solution using state-of-the-art and industry standard technologies.

Working collaboratively with this client, the ArborSys Group implemented a Controlled Document Management system to support the internal processes for the creation, review, electronic signature, approval and final effective watermarking and publishing of all controlled documents. The Quality Assurance Group, who owned these processes, was instrumental in working with our team to define and establish the standardized life cycles, workflows and electronic signature policies for the system. The published documents were made available to the consumers through an Intranet portal. Controlled documents addressed through this solution included:

Documentum’s Document Compliance Manager (DCM) 5.2 SP1 provided the facility for managing the effective controlled documents, including:

In order to provide enhanced usability for end-consumers, the ArborSys team published the approved documents to an intranet portal,  providing consumers with simple interfaces to easily drill-down through a standardized taxonomy, and securely locate/ view documents at either the corporate or departmental level. 

ArborSys is currently working with this client to migrate the application to DCM 5.3 to enhance the solution and address the limitations inherent in the DCM 5.2 version.

Using our significant domain experience and technical expertise, our team was able to successfully partner with our client to deliver a solution that significantly improved process efficiencies for the management of controlled documents within the organization, and delivered substantial business value to the client, including: