Regulatory documentation management at Sanofi
Case study: NextDocs for SharePoint. (information provided by the Vendor)
The challenge for the company was the manual process of finding, capturing, reviewing, approving, and storing documents for regulatory agencies. There was no consistent process for managing this task, no central document repository, and no significant automation.
They began searching for a document management solution designed to meet the needs of Life Sciences companies. This solution needed to comply with recognized standards, had to be easy to use by employees in many locations, and had to fit in with the company’s IT strategy.
Sanofi Pasteur MSD deployed the NextDocs Document Management System. Using Microsoft SharePoint Server as a foundation, the NextDocs solution provides a powerful document management, workflow, and collaboration solution that meets FDA 21 CFR Part 11 requirements.
Sanofi Pasteur MSD executives wanted a single solution that would provide company-wide regulatory compliant document management. That meant an FDA 21 CFR Part 11 compliant solution and that authorized users could access easily and consistently, from any location around the world. Furthermore, no additional management or administrative burdens could be placed on the company’s small IT department.
Sanofi Pasteur MSD uses Microsoft SharePoint Server for internal sharing and collaboration, so it wanted to find a standards-compliant document management solution that would leverage that investment.
Using built-in workflow and collaboration tools, the NextDocs software automated key tasks, including:
• Routing documents for review
• Reminding signatories when they needed to review and approve documents
• Capturing digital signatures
• Saving the final approved versions of the documents in a standard PDF format
• Storing these documents in a secure yet easily accessible data repository
The NextDocs Regulatory Document Management Module is a complete solution for managing documentation needed for CTD/eCTD and related filings in a SharePoint based system.
NextDocs guides users through the production of submission ready documents by enforcing the use of CTD/eCTD required granularity, requiring templates, producing PDF renditions that meet the myriad of agency requirements, and collecting 21 CFR Part 11 compliant electronic signatures.