Regulatory Document Management with Microsoft SharePoint 2010 and NextDocs (1 of 3)

The full set of documents that ultimately comprise an eCTD submission need to be managed through a complete lifecycle, from creation through submission. In addition to ensuring compliance with 21 CFR Part 11, a broad set of users need to have access to create, review, approve and update each document. During this session you will see how SharePoint 2010 can be used to address the complete set of requirements for managing regulatory documents in a life sciences environment.

This on-line session will include a complete demonstration of a system built on SharePoint 2010 and using the DIA Reference Model for managing regulatory documents and the associated metadata. Key topics that will be addressed:

- How SharePoint 2010 can address the complete set of 21 CFR Part 11 requirements including digital signatures, extended audit trails, and version control
- The role of the DIA Reference Model in simplifying and standardizing the organization of regulatory documents
- How SharePoint can act as a unified repository for managing all regulatory documents through their entire life cycle from creation through submission
- Integrating SharePoint 2010 with eCTD assembly and publishing solutions

Category:

Science & Technology

Tags:

• regulatory compliance software
• electronic submission
• regulatory submission
• ectd submissions
• submission management
• regulatory document management