Take Complete Control Over

Documents for Compliance

Freyr rDMS is an end-to-end electronic Regulatory Document Management System (rDMS/eDMS) entirely intended to enable Regulatory groups and sections within a life sciences organization. It can effortlessly create, capture, manage, organize, connect, deliver and archive Regulatory data and documents in a compliant, efficient and intuitive manner.

Although traditional document management software solutions are stereotypically fit for Regulatory needs, Freyr rDMS – an electronic Regulatory Document Management Software (eDMS/rDMS) is built ground-up, keeping specific distinctions and expectations of Regulatory strategies and operational functions in mind. Our solution maintains the whole document lifecycle from authoring, reviewing, approvals and archiving of Regulatory documents.

With the capacity to competently handle enterprise-wide documentation and with the ease of incorporation with legacy systems, Freyr rDMS provides a strong platform to address the crucial requirement for knowledge sharing across the organization.

Freyr rDMS Expertise

  • Parallel Review – Multiple User Access to Review and Update Documents
  • User Specific Document Related Notifications
  • Multiple Deployment Choices – Private, Public, Hybrid, On-premises and Cloud
  • Role-based and Version Controlled Documents
  • Ease of Integration with Legacy Systems – Internal and Third-Party

Freyr rDMS Capabilities

  • Intuitive and holistic Dashboards and Reports
  • Integrated Sharing Options - PDF, Excel, etc
  • Risk-based Compliant GxP Computerized Systems
  • Migration Friendly and Equipped with API and REST Full Services
  • Lifecycle Process Validation
  • Product and Process Interface Understanding
  • Application of Quality by Design Concepts
  • Seamless Document Monitoring
  • Advance Admin Functions to Manage Users and Monitor Ground-Level Activity
  • Integrating Multiple Language Resource Files
  • Search Functionality Across All Documents

Freyr rDMS Benefits

  • 21 CFR Part 11 Document Management System
  • Enhanced Agility
  • No Limitations to the Number of Documents
  • Intuitive User Experience and Simplified Product Usability
  • Seamless Third-party Integration

Freyr rDMS Workflow

 

Add Document

  • Document Owner adds document in any of the following formats - Word, PDF, Excel or PPT
  • Users can also can create new documents from the tool
 

Authoring

  • Author is responsible for editing content of the document
 

Review

  • This stage includes two levels of review
    • First review
    • Second review
  • Both users can add system level comments
  • Tool tracks all the comments made on the document

Approval

  • Approver can approve the documents and convert the Word doc to PDF format
  • Approver can also add a watermark and digitally sign the document
  • Approver documents are sent to all the Readers