Achieve Fast Compliance with FDA 21 CFR PART 820

FDA 21 CFR PART 820 Solution Benefits:

  • Adhere to FDA Quality Systems Regulations
  • Secure funding by quickly achieving FDA compliance
  • Support the QA team to work with FDA 21 CFR Part 820
  • Manage components from many different suppliers
  • Ease maintenance of Design Controls and Design Documents

Traditionally, to achieve FDA 21 CFR Part 820 compliance, you would labor through mountains of paper documents and disparate digital information, or invest in costly Document Management Systems. With Polarion you can create a Document History File (DHS) – including forensic level traceability – in minutes, and satisfy any audit.

FDA-21-part-820-compliance-whitepaper.png
How to Achieve FDA 21 Part 820 Compliance with Polarion

Our customers have recently discovered that using Polarion software for FDA 21 Part 820 compliance allows for utilizing smaller teams and deliver quicker results, with cost savings of between 35% to 50%.

FDA 21 CFR PART 820 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 tasks
  • Increased management oversight through advanced analytics and reports
sirona-success-story-polarion.png

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.”

 

lifewatch-success-story-polarion.png

Rafi Heumann | LifeWatch COO

Customer Success Story Lifewatch

"Polarion provides the foundation for submitting for FDA Clearance"

Learn More About Polarion for Medical Devices

Software Support & Maintenance Packages

Buy the support you need for your on-premise or hosted Polarion solution.

Learn More >

Contact Support

Customer Service Portal Access
Customer's Preferred Choice! Easiest way to ask & track progress over support cases.

Not a customer yet?
Contact us for general inquiries at:
USA      +1 877 572 4005
 Europe  +49 711 489 9969 - 0
 Live Chat

Training & Consulting

Our expert trainers can help you improve your development process with best practices, in-depth know-how, and tips-and-tricks to get the most out of your investment.

Learn more >

Effective Polarion® Licensing

Combine 5 Product Configurations - Optimize Capabilities - Lower Your Total Cost of Ownership.

Select the number and type of configurations you need to unify and empower different users on your team.

See more details about licensing >

 

See how you can accelerate innovation while ensuring quality and compliance

One of our Polarion experts will give you a one-on-one guided tour of the pioneering application lifecycle management software that is currently used by more than 10,000 firms worldwide to create better complex software, faster.


Give us a call: USA +1 877 572 4005 – Europe +49 711 489 9969 - 0

Try it now >