R&D Portal & Taxonomy

test_tubesA rapidly growing mid-size pharmaceutical company needed to address its substantial expanding R&D and QA document library. Multiple versions of R&D content were spread across 9 different discovery groups, replicated in hundreds of shared folders, partially stored in SharePoint, on personal hard drives and in Outlook mailboxes.  Group A had no ability to find content in Group B’s repositories so email was used as a conduit for sharing documents. This rapidly deteriorated the R&D groups’ ability to maintain solid version control for their FDA filings. In addition, the manual QA document process added another layer of complexity on top of the already labor intensive R&D document complexities.

These problems were exacerbated by the growth of the company and its acquisition of another pharmaceutical company. The grassroots methods of storing and sharing R&D documents and IP worked when the organization was young but were now rapidly breaking down.

An approach that re-designed the entire storage architecture for R&D and QA was needed. It needed to bring all the critical documents and content inside one structure but allow for a permissions-based approach to support sharing of content between groups, but only when appropriate.  A common user portal was also required but needed to be tailored to the specific user, their content and document needs and their specific group’s permissions. In addition, the new approach needed to integrate seamlessly with the redesigned QA document process and meet their stringent document tracking and control requirements.

InFuture LLC helped the client review and inventory all R&D and QA content and content processes from across nine different groups. InFuture LLC designed a comprehensive R&D and QA taxonomy and metadata structure. A single system that handled the needs of the R&D groups and QA was planned, designed, implemented and rolled out to the client with InFuture LLC’s support. Advanced QA workflows were developed and integrated into the document libraries. Numerous manual content processes were replaced with workflow automation. In addition, InFuture LLC helped the client plan and manage their document and content migration from the groups’ and QA shared drives and hard drives into the new environment.

As a result of their new approach, the need to share documents via email was reduced by nearly 95% as the new environment allowed seamless access between R&D groups. There was also a significant reduction in errors in FDA submissions as the use of incorrect document versions was eliminated.