Project Insights – Data migration as part of the regulatory transformation to Veeva Vault RIM

Colleague | Vigneshram Rengarajan

Author
Vigneshram Rengarajan
Principal Consultant @ fme Life Sciences

December 16, 2021

Project trigger

A leading global healthcare company was having difficulty in tracking their regulatory submissions which are managed across different systems. Also, there was a need to harmonize their regulatory processes across their different business units. Aiming at a standardized management of end-to-end submissions for both their pharamaceutical and vaccines business, they decided to migrate from ten different content and data management systems to Veeva Vault RIM.

Industry focus:Global healthcare
Product used:migration-center 3.16
Source systems:• Parexel Liquent Insight
• OpenText Documentum
• Rosetta
• File shares
Target systems:Veeva Vault RIM

Migration program approach

This project was executed following an agile approach with the vision to deliver a business value for every release. For each functional release a business process went live in Veeva Vault and also a migration release with the respective Vault RIM objects data (master data like product family, product variants, manufacturers, packaging etc. and regulatory registration data such as applications, submissions, regulatory objectives, and registrations), submission documents (different types of documents like regulatory, labelling, correspondence, quality etc.), and submission archives (i.e. eCTD submission archives) was migrated to Veeva Vault RIM.

The business process changes and training plans were integrated into the project plans for each migration. The overall migration strategy was defined at the initial stage of the project and then it was refined over the course of the project based on the specific requirements for each source system to continuously improve the migration time and quality for every migration release.

Seamless migration

fme’s migration-center software was used to successfully complete the scheduled migrations within the 3-year project timeline.  The migrations were delivered with little to no technical errors which enabled decommissioning to proceed with confidence on schedule. migration-center’s reporting capability was very much helpful in this large data migration. The result was an exponential growth in the number of documents and regulatory registrations data stored in the controlled repository and ensuring the single source of truth.

Project achievements

  • The unified platform promoted global business effectiveness

  • The new harmonized document management functionality enabled the customer’s business process improvements

  • The decommissioning of source systems reduced business risks and reduced maintenance and support costs

  • The program was completed on time and under budget 

The net result was that the program met or exceeded the customer’s expectations which is the primary measure of success at fme. 

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