Achieve Fast Compliance with FDA 21 CFR PART 11

FDA 21 CFR PART 11 Solution Benefits:

  • Meet FDA regulations for electronic records and signatures
  • Achieve compliant document management and records storage
  • Benefit from user/time stamping of records
  • Leverage unalterable document history including baselines
  • Improve management oversight with automated reports

Substituting paper records and handwritten signatures with electronic records and electronic signatures is a must for medical device manufacturers to achieve fast compliance with FDA 21 CFR Part 11. With Polarion's template you can exceed the requirement out-of-the-box.

Achieve FDA CFR 21 Part 11 Compliance with Polarion

Learn how existing customers enjoy the benefits of application lifecycle management (ALM) and discover how electronic records are maintained, tracked, and managed throughout their lifecycle.

FDA 21 CFR PART 11 Solution Highlights:

  • Accurate traceability for all artifacts throughout the entire lifecycle
  • Intuitive interface increasing end user acceptance and productivity
  • Out-of-the-box templates and processes can be easily customized
  • Real-time monitoring and reporting of defects
  • Fully traceable management of product complaints and adverse events
  • Automated routing, approval and incorporated escalation for overdue
  • Download Compliance response ERES

Michael Dalpiaz | Sirona Dental Systems

Customer Success Story Sirona

“Sirona Dental Systems uses Polarion to achieve compliance with medical device regulations like FDA or IEC 62304.”



Rafi Heumann | LifeWatch COO

Customer Success Story Lifewatch

"Polarion provides the foundation for submitting for FDA Clearance"

Learn More About Polarion for Medical Devices

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