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Software for 21 CFR Part 11

Why Polarion Software for FDA 21 CFR Part 11?

Instant Pricing

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.

Brochures

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Polarion Requirements

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Migrating from DOORS to Polarion

Curated Information

Traceability Basics

Creating a LiveDoc

Easy Linking for Traceability

Import a Word document into a LiveDoc

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