A Robust Methodological Approach for Replacing Global Electronic Document Management

Abstract

A new solution is needed to manage documents and submissions for the approval and maintenance of drug products at Merck Serono. As is often the case in merging pharmaceutical companies, new technology, harmonized processes, and process efficiency across the integrated departments are driving the change. This article describes the vision, approach, and methodology used to select new vendors and prepare for implementation of the new environment.

Mergers pose problems as the staff and tools are integrated from two previous companies. The selection of future systems must take into account the heritage from each and help form these companies into a new unit that can leverage the best of both worlds. In this case, the existing tools for electronic document management (EDM) and submission management (SUBM) were not found to be sufficient for the new business. It was going to be important for key departmental representatives to unite in the choice of a new way forward and contribute significantly to successful implementation across the enterprise spectrum. It would not carry the necessary impact to the company if any one organization were perceived to be the privileged owner of the new tools. Therefore, a dedicated team reporting to the CEO's office was put in place for the specific purpose of selecting and implementing the systems. We used many different methods to bridge the gaps and get consensus in the choices before the team, including a request for information, proof of concept, and a request for proposal.

Over 12,100 data points were collected in the analysis. Members of the project team and other participants from the business were educated in the features and functionality that are evident in the commercially available state-of-the-art solutions. Consensus for the selection of new tools for EDM and SUBM has been built through experience using the tools in a scripted, evaluative way. Many positive messages have been communicated as part of the process and the critical business stakeholders are supportive.

The process has been very successful. It has been accomplished on schedule and slightly below budget. The organization has been involved and user communities have had input to the process and the results. We are now ready to begin the implementation phase.