The client is the research and development organization within a top tier global pharmaceutical corporation. Its research focuses on the fields of cardiovascular, metabolism, immunology, infectious diseases, vaccines, neuroscience, and oncology.
The client chose Veeva Vault as its repository of choice for eTMF documents. Legacy documents needed to be migrated from a customized Documentum application containing three million documents. The data had to be migrated using a phased approach, which is often the case with eTMF content, where waves are defined according to groups of studies.
Valiance’s partner on this project is Veeva Systems. Veeva’s new cloud-based content management solution for the life sciences industry, Veeva Vault, is a best-of-breed cloud platform built for regulated content management.
Given the large volume of documents to be migrated – possibly the largest in Veeva Vault history at the time – an aggressive timeline loomed: the client wanted to complete an initial wave of 1.5 million documents in six to eight weeks. The document classifications in the source eTMF Documentum system needed to be translated to corresponding classifications in the Vault application, and there were complex mapping rules, which varied by document classification. Performance issues would arise when the project stressed the Veeva API, and Valiance collaborated with Veeva’s product development team to optimize the migration process.
Valiance’s TRUmigrate software offers native support for both Documentum and Veeva Vault. Connect to Documentum and Vault eTMF, then read in the respective schemas and you are ready to start the configuration process. Even with the complexity of the mappings and the treatment of the document classification mappings as a supplemental source, everything is configurable out of the box without custom code, scripts, or plug-ins.
Document classification mapping is a user driven process and with over 500 mappings, there is plenty of opportunity for error. Valiance worked with the client to create and manage a straightforward spreadsheet template. Valiance and the client can easily review and edit the classification spreadsheet to assure it meets all requirements. Additionally, this classification spreadsheet is integrated with TRUmigrate and is part of the typical eTMF migration configuration.
As is often the case with larger scale migrations, there was a need to implement a multi-batch, multi-threaded process to meet performance objectives. This becomes straightforward with Valiance’s TRUconsole to define, manage, and automate the execution of parallel and successive serial batch runs.
Valiance worked closely with the client and Veeva to monitor the migration during the dry runs, where the migration process may be informally tested. When the imports slowed down as repository volume increased, Veeva identified opportunities to tune the API for better performance. Additionally, the client recognized that many of the studies that were initially deemed “closed and locked” were just closed and users were still editing content.
Valiance collaborated with Veeva to address the performance challenges. The changes to the scope of locked content were efficiently managed between Valiance and the client. The results: the initial migration was successfully completed with 1.5 million documents, and the client went into production on time with the scope of the migration focused on locked content.