FDA Compliance Software

AssurX’s FDA Compliance Software automates quality management processes, ensuring adherence to FDA regulations like 21 CFR Part 11. Our platform integrates with enterprise systems, enhancing visibility and control over compliance activities. Experience streamlined workflows and real-time insights to maintain high compliance standards.

13 07, 2022

QMS Configuration vs. Out-of-the-Box: Real-World Considerations

By |2024-06-03T13:28:45+00:00July 13th, 2022|Document Management, FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management, Risk Management|

When evaluating an automated QMS, the question to invest in configuration vs. ou [...]

26 05, 2022

EU Medical Device Regulation Still Presents Challenges and Opportunities

By |2024-12-31T23:16:11+00:00May 26th, 2022|EU IVDR, EU MDR, FDA Regulated Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management, Risk Management|

EU Medical Device Regulation (MDR) has been in effect for almost a year. As anti [...]

20 04, 2022

Understanding FDA Alignment of ISO 13485 with Quality System Regulation

By |2024-03-04T21:30:05+00:00April 20th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]

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