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.
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%.
Michael Dalpiaz | Sirona Dental Systems
“Sirona Dental Systems uses Polarion to achieve compliance with medical device regulations like FDA or IEC 62304.”
Rafi Heumann | LifeWatch COO
"Polarion provides the foundation for submitting for FDA Clearance"
Software Lifecycle Process Template: IEC 62304 >
Quality System (QS) Regulation/Current Good >
Manufacturing Practices (CGMP) Template: FDA 21 CFR Part 820 >
Electronic Records/Signatures Template: FDA 21 CFR Part 11 >
Benefit/Risk Determination Template: ISO 14971 >
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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