Blog2024-01-24T16:53:39+00:00

AssurX Blog

Straight talk for regulated industries.

2011, 2023

The Importance of a Document Management System

November 20th, 2023|Corrective Action (CAPA), Document Management, Quality Management, Regulatory Compliance Management|

There’s an old saying in regulated industries: if it isn’t documented, it didn’t happen. In the past, maintaining fully compliant documentation meant handling a mountain of paper, crea [...]

211, 2023

NERC CIP-013: Cyber Security – Supply Chain Risk Management for Utilities

November 2nd, 2023|Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management|

Supply chain risk management is of paramount importance to cyber security for utilities. That’s because any supply chain disruption can have severe consequences for these critical infr [...]

1708, 2023

Aligning Incident Management with ISO 45001 Requirements

August 17th, 2023|Energy & Utilities Industry, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management|

The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2021 according to the ISO Survey. This occupational health and safety standard is especially prevalent in [...]

808, 2023

EHS Incident Management and Root Cause Analysis

August 8th, 2023|Energy & Utilities Industry, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management|

Workplace safety incidents are a key driver of risk in manufacturing organizations. There are the obvious risks to workers, whose ability to make a living directly depends on their emp [...]

2607, 2023

Risk Management in ISO 13485

July 26th, 2023|Document Management, FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Quality Management, Risk Management|

In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Qua [...]

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