Wed, 07/16/2025 - 12:01
Spreadsheets are usually the first tool used to manage suppliers, and the first to become a liability. Important updates get buried. Repeat supplier problems start popping up. Along the way, you start to wonder whether that cheaper vendor is really…
Wed, 07/09/2025 - 12:03
Many companies are still clinging to paper-based and unconnected electronic processes, despite the clear disadvantages. Without modern tools like QMS software, these organizations risk compromising product quality, falling behind in compliance, and…
Tue, 05/27/2025 - 12:02
Every day, quality leaders face a variety of production and process issues. Although some problems are easy to fix, others require deeper investigation, such as using a 5 Whys analysis or fishbone diagram. But then there are the stubborn, recurring…
Wed, 04/16/2025 - 00:02
The pharmaceutical industry and the medical device industry have unique ways of defining terms like deviation and nonconformance. Often, this leads to confusion about how events should be classified and managed.
This article explains the difference…
Tue, 03/18/2025 - 12:03
Quality risk management (QRM) has become a crucial tool for ensuring regulatory compliance worldwide. It plays a central role in ISO management system standards and regulations, as well as the EU Medical Device Regulation (MDR/IVDR), FDA 21 CFR 820…
Thu, 01/30/2025 - 00:02
The U.S. Food and Drug Administration’s inspections and subsequent actions all come down to product quality. Quality system failures result in noncompliances that FDA inspectors target during their inspections. If there is any doubt that a…
Wed, 01/29/2025 - 00:01
In April 2018, the U.S. Food and Drug Administration (FDA) approved the first artificial intelligence-powered diagnostic system, a software program used to detect diabetes-related vision loss.
Since then, the industry has seen explosive growth of…
Tue, 11/12/2024 - 12:02
In the highly regulated world of life sciences, data integrity isn’t optional; it’s essential. The ALCOA principles—attributable, legible, contemporaneous, original, and accurate—provide a foundational framework for ensuring data are reliable and…
Tue, 09/24/2024 - 12:02
How can a quality manager secure stakeholder engagement and hold individuals accountable for the quality of their work throughout the corrective and preventive action (CAPA) cycle?
With the burden of quality and compliance on their shoulders, it…
Thu, 08/01/2024 - 12:03
There’s no question about it: Should an auditor or inspector visit your facility, one thing that will certainly be under the microscope is your corrective and preventive action (CAPA) system.
CAPA management is a recurring theme in U.S. Food and…
