Client Challenge

The client organization had grown rapidly and wanted to migrate from MS SharePoint® to a robust system that was 21 CFR Part 11 compliant. The company also wanted to consolidate all documentation (hardcopy and electronic) into one centralized repository.

The company needed to identify one central (and optimal) repository to be used for document management. They needed a roadmap and plan to migrate to the identified solution that would not impact critical ongoing daily activities.

Red Nucleus Solution

The Red Nucleus team facilitated the definition of user requirements for a document repository, publishing software, and registration management tool. We developed a 21 CFR Part 11 checklist for compliance and arranged interviews with vendors to compare their system offerings against the user requirement and compliance checklist. In this process, we gained alignment across all key stakeholders and established a realistic plan/roadmap for migration to the new system.


The company selected and implemented a document management solution that was adopted across all of R&D. Documents were successfully migrated to the new, centralized system.