FDA Regulated Industries

The “FDA Regulated Industries” category at AssurX helps organizations meet the strict requirements of the U.S. Food and Drug Administration. This section offers insights into quality management, compliance strategies, and process optimization for FDA-regulated sectors. It covers topics like navigating complex regulations, ensuring product safety, and maintaining high quality. AssurX provides expertise to help professionals achieve compliance, boost efficiency, and drive innovation, ensuring products meet all regulatory requirements.

9 10, 2025

FSVP Violations Under Fire: FDA’s 2025 Warning Letters and the Listeria Outbreak Exposing Global Food Supply Chain Risk

By |2025-10-09T15:54:29+00:00October 9th, 2025|FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management, Risk Management|

In 2025, the U.S. Food and Drug Administration (FDA) has continued its crackdow [...]

28 07, 2025

5 Essential Elements Shared by Leading Supplier Quality Management Systems

By |2025-07-28T16:33:25+00:00July 28th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

Global-scale events have tested the bounds of a supply chain system. The coronav [...]

9 07, 2025

QMS Validation: How CSA Reduces Documentation Without Increasing Risk

By |2025-07-08T20:34:27+00:00July 9th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

Documentation has long been at the heart of quality management system (QMS) val [...]

26 06, 2025

Supplier Scorecards vs. Spreadsheets: Risks of Manual Tracking

By |2025-06-26T14:08:20+00:00June 26th, 2025|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

Spreadsheets are usually the first tool used to manage suppliers, and the first [...]

17 06, 2025

QMS Software: When to Configure and When to Customize

By |2025-06-17T15:25:23+00:00June 17th, 2025|Archives, eMDR, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, SaaS & Cloud Computing|

When it comes to managing quality and compliance in today’s regulated industries [...]

21 05, 2025

Human Factors in CAPA Part III: How To Secure Management Commitment

By |2025-05-21T13:32:55+00:00May 21st, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In the third and final part of our Human Factors in CAPA series, we’re tackling [...]

14 05, 2025

Human Factors in CAPA Part II: How to Improve CAPA Accountability

By |2025-05-19T18:44:35+00:00May 14th, 2025|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management|

In Part I of our Human Factors in CAPA series, we talked about employee engagem [...]

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