AssurX Blog
Straight talk for regulated industries.
Preparing for ISO 13485 Harmonization: Where Do Things Stand Today?
In January 2024, the U.S. Food and Drug Administration (FDA) issued a final rule harmonizing its Quality System Regulation (QSR) with ISO 13485 for medical device quality management. [...]
5 Places to Use a FMEA in Your Quality Process
Before any road trip, it makes sense to check your tire pressure along with levels of engine oil, windshield wiper fluid, and coolant. By doing so, you can avoid some of the most comm [...]
The Role of Technology in Supporting ALCOA Principles: Strengthening Data Integrity in Life Sciences with Quality Management Software
In the highly regulated world of life sciences, data integrity is not optional – it’s essential. The ALCOA principles -- Attributable, Legible, Contemporaneous, Original, and Accurate [...]
Internal Controls for More Than Just Compliance
For the Utility industry, regional entities are increasingly focusing on Internal Controls as a measuring stick for overall compliance performance. Developing and executing rock-solid [...]
Out of Control Internal Controls: Mastering Complexity in NERC Regulatory Compliance
As energy utilities increasingly adopt advanced technologies and face ever-evolving regulatory requirements, the need for strong internal controls has never been more crucial. If you' [...]
Ways to Influence Stakeholder Buy-In During the CAPA Process
How can a quality manager secure stakeholder engagement and hold individuals accountable for the quality of their work throughout the CAPA cycle? With the burden of quality and compli [...]
