Polarion | 21 CFR Part 11
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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.  

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  • 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.

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Brochures

Curated Information

Traceability Basics

Creating a LiveDoc

Easy Linking for Traceability

Import a Word document into a LiveDoc

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