AssurX Blog
Straight talk for regulated industries.
How Hybrid Audits Can Help MDR Compliance in the European Union
The shortage of notified bodies (NB) in the European Union is a key challenge for device manufacturers struggling with Medical Device Regulation (MDR) compliance. As a result, the EU’s [...]
8 CAPA KPIs You Should Be Measuring Now
Corrective and preventive action (CAPA) is a core function in any quality management system (QMS) and critical to the Plan-Do-Check-Act process approach. Like any quality process, trac [...]
Finding the Root Cause: Where Manufacturers Go Wrong
Finding the root cause of a manufacturing quality issue prevents unsafe or poor quality products from reaching consumers. Unfortunately, many investigations don't get to the true root [...]
5 Strategies to Improve Quality Incident Management and Root Cause Analysis
Imagine you’re doing a pre-shipment inspection on multiple pallets containing product canisters. As a result of the inspection, you observe wrinkled labels throughout the lot. While th [...]
AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables
RENO, NEVADA, UNITED STATES, October 4, 2022 -- AssurX, a leader in quality management and regulatory compliance systems, will be attending this year’s ASQ Quality 4.0 Conference being [...]
5 Building Blocks You Need for a Quality 4.0 Foundation
Market changes and disruptions such as the global pandemic are driving companies to adopt Industry 4.0 in their manufacturing operations. Many companies are investing in smart manufact [...]
