Blog2025-03-18T10:11:14+00:00

AssurX Blog

Straight talk for regulated industries.

211, 2022

Finding the Root Cause: Where Manufacturers Go Wrong

November 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 quality products from reaching consumers. Unfortunately, many investigations don't get to the true root [...]

1210, 2022

5 Strategies to Improve Quality Incident Management and Root Cause Analysis

October 12th, 2022|FDA Regulated Industries, Food & Beverage Industry, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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 [...]

510, 2022

AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables

October 5th, 2022|FDA Regulated Industries, Manufacturing Industries, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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 [...]

2909, 2022

5 Building Blocks You Need for a Quality 4.0 Foundation

September 29th, 2022|Complaint Management, Document Management, Manufacturing Industries, Quality Management|

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 [...]

2209, 2022

Understanding ALCOA+ Principles and Data Integrity for Pharma

September 22nd, 2022|FDA Regulated Industries, Manufacturing Industries, Pharmaceutical Industry, Quality Management|

Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) current good manufacturing practices (cGMP) regulations. Pharmaceutical manufacturers must ensure data is rel [...]

1509, 2022

Pharmaceutical Warning Letters Reveal CGMP Failures

September 15th, 2022|FDA Regulated Industries, Manufacturing Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. However, it’s an area where many pharma manufacturers still struggle. In fact, 30 percent of FDA pharma [...]

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