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Quality Management System

AssurX Quality Management Systems (QMS) provide comprehensive solutions to automate and streamline compliance processes. Our platform enhances visibility and control, ensuring adherence to industry standards like ISO 9001 and FDA regulations. Experience seamless integration and real-time insights to improve quality management across your organization.

23 01, 2025

Mastering Quality: Proven Risk Mitigation Strategies for Flawless Manufacturing

By |2025-04-04T02:25:48+00:00January 23rd, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Risk Management|

Risk mitigation is crucial for manufacturing quality products because it helps [...]

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9 01, 2025

How to Achieve Manufacturing Quality Compliance Success: Apply Automation

By |2025-03-18T09:00:45+00:00January 9th, 2025|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

FDA inspections and subsequent actions all come down to product quality. Qualit [...]

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18 12, 2024

Overcoming the Challenges of Medical Device Complaint Handling with AI: How 3Analytics Leads the Way

By |2025-04-04T02:28:15+00:00December 18th, 2024|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

The medical device industry plays a pivotal role in global healthcare, deliveri [...]

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5 12, 2024

AI in Medical Device Manufacturing: How It’s Transforming an Industry

By |2025-04-04T01:31:15+00:00December 5th, 2024|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In April 2018, the U.S. Food and Drug Administration (FDA) approved the first A [...]

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14 11, 2024

Critical Aspects of Quality Management Systems: Focusing on the Validation Process

By |2025-04-04T02:21:19+00:00November 14th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In regulated industries like pharmaceuticals, medical devices, and food manufac [...]

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30 10, 2024

Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?

By |2025-04-04T02:28:32+00:00October 30th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rul [...]

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9 10, 2024

The Role of Technology in Supporting ALCOA Principles: Strengthening Data Integrity in Life Sciences with Quality Management Software

By |2025-04-04T02:28:48+00:00October 9th, 2024|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In the highly regulated world of life sciences, data integrity is not optional [...]

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