Implementing a unified and IDMP compliant RIMS

For a top 10 Pharma Generics company, ION Pharma supported the end-to-end program for implementing an Ennov RIMS and sDMS solution, from requirements gathering, through to software selection, configuration, data migration, validation and implementation.

The Problem

The client operated three independent, on-premise solutions for Regulatory Information Management (RIMS), Submission Document Management (sDMS) and Publishing. Both RIMS and sDMS had reached their end of life, and particularly the replacement of the RIM system had become urgent due to the ending support by the vendor.

The Objective

To become future proof, the client was looking to replace the on-premise RIMS and sDMS with a single, cloud-based solution that is fully IDMP compliant. Furthermore, to keep the interface with RIMS and sDMS, also the existing Publishing system required upgrading from on-premise to cloud base.

A key element in such large-scale program is bringing the plans together from the various configuration, data migration and validation workstreams, integrating and aligning them into a single, overall plan that is both realistic and manageable.

Particularly challenging for the customer was the conversion from a legacy, xEVMPD focussed data model to a fully IDMP compliant data model. This was further complicated through many data quality issues, caused by changing legislation and business rules over the past 20 years, as well as 3 previous data migrations with uncomplete legacy data.

The Solution and Approach

We worked together with the various user groups to gather all requirements as input for the Request for Proposal, and subsequentially managed the Tender and Software Selection process.

After having managed the overall tender process, we provided input into the overall project planning and received accountability for the delivery of the RIM configuration, providing the linking pin between client Regulatory Affairs business and the Vendor’s configuration specialists. On successful and on-time delivery of the RIMS configuration track, ION Pharma received overall accountability for the RIMS workstream to bring the data migration back on track and to ensure all required validation activities were delivered.

The Results

Our extensive experience in delivering such complex programs, helped the customer to shape the overall project plan, as well as to take the necessary corrective actions to ensure a successful go-live of the system.

Detailed understanding of the business processes, the data model and configuration limitations of the system were not only key to the software selection, but subsequentially also to the configuration, the data migration and the change management process with development of training materials and work instructions.

This resulted in a successful delivery of the overall project which concluded with a very smooth transition and hypercare period, with only few minor corrections needed after go-live.