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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…![](/sites/default/files/editorial_images/Bulbs1000.jpg)
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…![](/sites/default/files/editorial_images/QMS1000.jpg)
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…![](/sites/default/files/editorial_images/cms1000_0.jpg)
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…![](/sites/default/files/editorial_images/compliance1000_0.jpg)
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…![](/sites/default/files/editorial_images/Audit310.jpg)
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…![](/sites/default/files/editorial_images/Assur310.jpg)
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…![](/sites/default/files/editorial_images/DocPic310.jpg)
Mon, 12/18/2023 - 12:02
There’s an old saying in regulated industries: If it isn’t documented, it didn’t happen.
In the past, maintaining fully compliant documentation meant handling a mountain of paper, which created extra work—and hidden risks—from a quality perspective…![](/sites/default/files/editorial_images/RA-640_0.jpg)
Tue, 11/07/2023 - 11:03
In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management System Regulation (QMSR) will harmonize with ISO…![](/sites/default/files/editorial_images/Welding310.jpg)
Wed, 10/04/2023 - 12:03
The number of ISO 45001 certificates is growing fast, jumping 54% from 2020 to 2021, according to the ISO Survey.
This occupational health and safety standard is especially prevalent in manufacturing, where managing safety incidents is a core…