Two biopharma service providers have implemented enterprise document systems based on the Microsoft SharePoint platform.
In the first implementation, service provider Quotient Bioresearch has automated controlled document sharing across four U.K. sites via SharePoint. At the same time, the early-stage drug specialist has set up a 21CFR Part 11 solution for electronic records and signatures.
Quotient has implemented GxPi's x-docs server across the sites, replacing systems unable to provide group-wide support. GxPi developed a module in which Quotient can create standard procedures, and then review, approve, publish and distribute them. Compliant audit history and security access were among system requirements. Features include document-specific auto-numbering and integrated change request processes.
In another implementation, consultancy and contractor PCS chose Mission3 for a SharePoint Part 11-compliant document and submission management tools. PCS, for Pharma Consulting Solutions, offers regulatory submission-management support to its clients. The consultancy sought a SaaS solution to minimize IT spending. PCS says in a release that its dashboard was up and running within a month, and expects to submit an NDA in the coming quarter.
- here's the GxPi release
- see the Mission3 announcement