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…
Wed, 07/10/2024 - 12:03
Customer complaints are a fact of life in any industry. Even though manufacturers would prefer not to receive complaints, they do come with a silver lining. Managed effectively, they play an important role in improving your products and processes…
Wed, 06/19/2024 - 12:02
Look through even a few FDA warning letters and you’re likely to find violations related to change management.
For instance, a recent warning letter from the U.S. Food and Drug Administration cited a pharmaceutical manager for changing drug…
Wed, 04/24/2024 - 12:02
An analysis of U.S. Food and Drug Administration (FDA) warning letters by the Food and Drug Law Institute reveals a perhaps not-so-surprising link between training gaps and FDA violations.
It’s one of several factors motivating companies to switch…
Thu, 04/04/2024 - 12:02
Companies today implementing automated compliance management systems are motivated by a wide variety of factors.
For many, it’s about reducing manual labor hours required to execute quality processes—and achieving greater efficiency and…