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Enterprise Quality Management System

6 06, 2023

Linking Design Controls and Risk Management in the QMS
Linking Design Controls and Risk Management in the QMS

Linking Design Controls and Risk Management in the QMS

By Stephanie Ojeda|2023-06-06T18:33:52+00:00June 6th, 2023|Document Management, FDA Regulated Industries, Food & Beverage Industry, Quality Management, Regulatory Compliance Management|

Design controls are a frequent citation in 483 observations and warning letters [...]

30 05, 2023

Complaint Management for Life Sciences with an Automated QMS
Complaint Management for Life Sciences with an Automated QMS

Complaint Management for Life Sciences with an Automated QMS

By Stephanie Ojeda|2023-05-30T15:33:33+00:00May 30th, 2023|Complaint Management, Document Management, Manufacturing Industries, Medical Device Industry, Quality Management|

Effective complaint handling is fundamental to life sciences quality management, [...]

27 04, 2023

AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)
AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)

AssurX Exhibiting at ASQ World Conference on Quality & Improvement (WCQI)

By Tim DeMuth|2023-04-27T17:53:40+00:00April 27th, 2023|Complaint Management, Document Management, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

AssurX will be exhibiting at this year’s ASQ World Conference on Quality & [...]

25 04, 2023

Update: EU Medical Device Regulation Deadlines Extended
Update: EU Medical Device Regulation Deadlines Extended

Update: EU Medical Device Regulation Deadlines Extended

By Stephanie Ojeda|2023-04-25T16:26:48+00:00April 25th, 2023|Document Management, eMDR, EU IVDR, EU MDR, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

European Union (EU) Medical Device Regulation (MDR) and In-Vitro Device Regulati [...]

13 04, 2021

Supplier Quality Management: A New QMS-Based Approach
Supplier Quality Management: A New QMS-Based Approach

Supplier Quality Management: A New QMS-Based Approach

By AssurX Blog|2021-04-13T07:48:10+00:00April 13th, 2021|Manufacturing Industries, Quality Management, Regulatory Compliance Management|

According to research firm LNS Research, fewer than 1 in 5 companies have a robu [...]

22 03, 2021

5 Quality Management Trends to Watch in 2021
5 Quality Management Trends to Watch in 2021

5 Quality Management Trends to Watch in 2021

By AssurX Blog|2021-03-22T07:30:38+00:00March 22nd, 2021|FDA Regulated Industries, Manufacturing Industries, Quality Management, Regulatory Compliance Management|

2020 represented the sharpest economic slowdown in modern history. Nonetheless, [...]

9 02, 2021

EQMS Implementation: How to Lead Organizational Change
EQMS Implementation: How to Lead Organizational Change

EQMS Implementation: How to Lead Organizational Change

By AssurX Blog|2021-02-09T06:10:12+00:00February 9th, 2021|Manufacturing Industries, Quality Management, Regulatory Compliance Management|

The Kübler-Ross Change Curve®, adapted from the original five stages of grief (o [...]

19 12, 2019

Best Practices for 21 CFR Part 11 Compliance
Best Practices for 21 CFR Part 11 Compliance

Best Practices for 21 CFR Part 11 Compliance

By AssurX Blog|2019-12-19T07:00:30+00:00December 19th, 2019|Document Management, eMDR, FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

With more modern-day compliance enforcement, life science manufacturers and dist [...]