Audience
Operational and regulatory teams looking for a toolkit to prepare complete and compliant submission ready documents and records
About RegDocs Connect
RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution. Automated workflows manage your records lifecycle from draft to final, enabling your team to be in complete control of your regulatory documents at all times. Mapping of document types to the EDM reference model and eCTD facilitates organization and retrieval of documents for inclusion in regulatory submissions. Proprietary tools such as PDF/A Publishing, document classification, and unique document identifiers provide a powerful regulatory document management solution that pulls information from across your organization, into one manageable solution. With the rise of electronic submissions to regulatory agencies and the increased complexity of drug development, the ability to produce submission-ready, quality content
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Our capabilities are as follows:
• AI Application Builder
• Regulatory Intelligence
• Change Assessment
• Standards Management
• Country-Specific Templates
• Distributor Collaboration
• AI Document Management
• Tracking & Reporting
• Alerts and Notification
• Product Management
• Claims Management
• EUDAMED
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-Endless Workflow Configurations
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Integrations
Company Information
Montrium
Canada
www.montrium.com
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Product Details
Platforms Supported
Cloud
Training
Documentation
Live Online
Webinars
In Person
Support
Phone Support
Online
RegDocs Connect Frequently Asked Questions
RegDocs Connect Product Features
Document Management
Collaboration Tools
Supported
Compliance Tracking
Supported
Document Archiving
Supported
Document Assembly
Supported
Document Retention
Supported
Electronic Signature
Supported
File Recovery
Supported
File Type Conversion
Supported
Version Control
Supported
Access Controls
Not Supported
Archiving & Retention
Not Supported
Document Capture
Not Supported
Document Conversion
Not Supported
Document Delivery
Not Supported
Document Indexing
Not Supported
Email Management
Not Supported
Forms Management
Not Supported
Full Text Search
Not Supported
Offline Access
Not Supported
Optical Character Recognition
Not Supported
Print Management
Not Supported
