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…
Thu, 03/21/2024 - 12:02
Implementing an automated compliance management solution is a mammoth undertaking with high stakes and potentially high returns for those who navigate the process successfully.
Get it right and you could save thousands of labor hours, avoid…
Mon, 03/11/2024 - 13:03
As U.S. Supreme Court Justice Louis D. Brandeis famously wrote, “Sunlight is said to be the best of disinfectants.”
In the field of quality, internal audits are the equivalent of sunlight. Like spring cleaning, internal audits provide the…
Wed, 02/28/2024 - 12:03
Formal complaint management is a requirement in regulated industries such as medical device and pharmaceuticals under U.S. Food and Drug Administration (FDA) and other international regulations.
The FDA mandates that medical device companies, for…