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Software for 21 CFR 820

Why Polarion Software for FDA 21 CFR 820?

Polarion provides a templated approach to support to the 21 CFR 820 standard.  

  • Complete traceability across all artifacts

  • Monitoring and escalation complaints, non-conformances and defects

  • Control of design documents and design controls

  • Easy configuration for business process rules


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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