Manage the Complete Lifecycle of Regulatory and Submission Documents
The NextDocs Regulatory Documents Module provides a SharePoint-based, out-of-the-box solution to the challenge of collecting and managing the wide array of documents that comprise a regulatory submission.
The NextDocs Regulatory Documents Module is part of the NextDocs Document Management System, which includes a comprehensive set of features that addresses all eGxP and 21 CFR Part 11 requirements.
Like all NextDocs solutions, it is “Built in SharePoint” and ready-to-deploy, which means faster deployment, higher adoption rates and dramatically lower costs than proprietary systems built on legacy platforms.
By providing template-based folder structures, the NextDocs Regulatory Documents Module enforces consistent folder structures and naming conventions. And with our optional Microsoft Word-based submission document templates, authors automatically create documents with consistent formatting and structure so that they are ready to integrate with your submission publishing solution.
The NextDocs Regulatory Documents Module includes:
- A ready-to-use solution for managing all types of regulatory content including labeling documents,
correspondence and forms. - Seamless integration with the leading submission management systems from vendors including:
• Liquent
• ISI
• Datafarm
• Extedo
- Optional Microsoft Word-based submission document templates for consistent formatting and structuring of documents in accordance with regulatory guidance.
- Automated workflow with lifecycle management from creation through review, effectivity and retirement.
- Fully configurable visual workflow creation Functionality that addresses all eGxP and 21 CFR Part 11 requirements.
- Role-based electronic sign-off and digital signatures
