FDA Regulation

7 03, 2023

FDA Warning Letters Show Document Management System Issues in Food Industry

By |2023-09-28T21:07:07+00:00March 7th, 2023|Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Quality Management|

Documentation is a subject that comes up frequently in U.S. Food and Drug Admini [...]

15 11, 2022

8 CAPA KPIs You Should Be Measuring Now

By |2023-11-14T23:15:43+00:00November 15th, 2022|Corrective Action (CAPA), FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Corrective and preventive action (CAPA) is a core function in any quality manage [...]

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 [...]

31 03, 2022

miraDry Implements AssurX Quality Management and Regulatory Compliance Software

By |2024-01-13T02:06:41+00:00March 31st, 2022|Complaint Management, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leader [...]

31 03, 2022

How an EQMS can Reduce CAPA and Complaint Observation Trends

By |2024-03-26T20:26:06+00:00March 31st, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

As we move through 2022, we look forward to new opportunities, new challenges, a [...]

Go to Top