Regulatory Document Management System

PhlexDMS is an essential technology to help you manage all your documents. And when it's compliance you're looking for with your regulatory documents - it is all in PhlexDMS.  Simple to use and very scure – documents can be easily shared in controlled environment  with your colleagues and partners.

21 CFR Part 11 Compliance

Integrated Document Tagging 

Built-in PDF Rendering

Creates documents in compliance with global requirements

  • Expedites the creation of new documents and the uploading of existing documents including large content libraries efficiently from outside the system.
  • Configures review and approval workflows to support paperless, efficient document creation, editing and approval processes.
  • Documents digital signatures according to FDA requirements (21 CFR part 11).
  • Navigates through large content libraries with ease .
  • Converts documents into eCTD-compliant PDF renditions automatically.
  • Controls document versions and allows only “submission ready” documents to be used in the PhlexSubmission module.
  • Recognizes and addresses the need for a more collaborative workspace where both internal and external users can work more effectively.