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Software for 21 CFR Part 11

Why Polarion Software for FDA 21 CFR Part 11?

Polarion provides a templated approach to support to the FDA 21 CFR 11 standard for electronic signatures.  

  • Supports FDA guidance for electronic signatures and records

  • Complies with document manage and the storage of records

  • Full document history and traceability of changes

  • Creation of baseline for a formal approved document state

  • Easy to configure reports for documentation and current status.


Never worry about an upcoming audit as the audit status is continually maintained across all systems and teams.


Curated Information

Traceability Basics

Creating a LiveDoc

Easy Linking for Traceability

Import a Word document into a LiveDoc

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