Regulatory Compliance Management

The “Regulatory Compliance Management” category at AssurX is dedicated to helping organizations navigate the complex landscape of regulatory requirements. This section provides practical tools and expert insights to ensure adherence to industry standards and regulations. It covers a range of topics, including compliance strategy development, risk assessment, and the integration of compliance management systems. By exploring these resources, professionals can streamline their compliance processes and mitigate risks effectively. AssurX equips you with the knowledge and solutions needed to maintain compliance and drive operational excellence.

24 02, 2023

AssurX Adds EHS Incident Management to its Quality Management Platform
AssurX Adds EHS Incident Management to its Quality Management Platform

AssurX Adds EHS Incident Management to its Quality Management Platform

By Tracy Orlick|2024-01-13T02:18:19+00:00February 24th, 2023|Document Management, Energy & Utilities Industry, NERC Compliance, Quality Management, Regulatory Compliance Management|

PRESS RELEASE: ASSURX ADDS ENVIRONMENTAL HEALTH AND SAFETY (EHS) INCIDENT MANAG [...]

7 02, 2023

Planning for Successful Preparation of the NERC CIP ERT
Planning for Successful Preparation of the NERC CIP ERT

Planning for Successful Preparation of the NERC CIP ERT

By Kathryn Wagner|2024-01-13T01:42:24+00:00February 7th, 2023|Document Management, Energy & Utilities Industry, NERC Compliance, Quality Management, Regulatory Compliance Management|

Cybersecurity regulations in the energy industry create a constantly evolving ch [...]

31 01, 2023

Tips for Preparing for an ISO Certification Audit
Tips for Preparing for an ISO Certification Audit

Tips for Preparing for an ISO Certification Audit

By Stephanie Ojeda|2024-06-03T14:12:38+00:00January 31st, 2023|Document Management, Manufacturing Industries, Medical Device Industry, Quality Management, Regulatory Compliance Management|

Recent ISO data shows a growing number of certificates being issued across all s [...]

19 01, 2023

An Overview of the FDA Draft of CSA Guidance for Quality Systems
An Overview of the FDA Draft of CSA Guidance for Quality Systems

An Overview of the FDA Draft of CSA Guidance for Quality Systems

By Stephanie Ojeda|2023-01-19T10:01:40+00:00January 19th, 2023|Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

In September 2022, the (FDA) released draft computer systems assurance (CSA) gui [...]

12 01, 2023

6 Common Reasons External Quality Audits Fail
6 Common Reasons External Quality Audits Fail

6 Common Reasons External Quality Audits Fail

By Stephanie Ojeda|2024-03-26T20:24:48+00:00January 12th, 2023|Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

In FDA and ISO environments, quality audits are a process of examination and sub [...]

3 01, 2023

Root Cause Analysis Tools: Which Should You Use?
Root Cause Analysis Tools: Which Should You Use?

Root Cause Analysis Tools: Which Should You Use?

By Stephanie Ojeda|2024-01-13T02:12:13+00:00January 3rd, 2023|Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Root cause analysis is a common weak spot in manufacturing, causing numerous qua [...]

15 12, 2022

FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls
FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls

FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls

By Stephanie Ojeda|2024-06-25T18:23:15+00:00December 15th, 2022|FDA Regulated Industries, Quality Management, Regulatory Compliance Management|

Alignment with the Food Safety Modernization Act (FSMA) is necessary for manufac [...]

29 11, 2022

How Hybrid Audits Can Help MDR Compliance in the European Union
How Hybrid Audits Can Help MDR Compliance in the European Union

How Hybrid Audits Can Help MDR Compliance in the European Union

By Stephanie Ojeda|2022-11-29T08:48:10+00:00November 29th, 2022|eMDR, EU MDR, Medical Device Industry, Quality Management, Regulatory Compliance Management|

The shortage of notified bodies (NB) in the European Union is a key challenge fo [...]

15 11, 2022

8 Essential CAPA KPIs to Measure
8 Essential CAPA KPIs to Measure

8 Essential CAPA KPIs to Measure

By Stephanie Ojeda|2024-07-01T21:28:46+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 manag [...]

2 11, 2022

Finding the Root Cause: Where Manufacturers Go Wrong
Finding the Root Cause: Where Manufacturers Go Wrong

Finding the Root Cause: Where Manufacturers Go Wrong

By Stephanie Ojeda|2024-03-04T21:11:44+00:00November 2nd, 2022|FDA Regulated Industries, Food & Beverage Industry, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]