AssurX Blog
Straight talk for regulated industries.
Critical Aspects of Quality Management Systems: Focusing on the Validation Process
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated Quality Management System (QMS) is [...]
How Compliance Software Can Help Manage CIP-007: Strengthening Critical Infrastructure Security
In today’s interconnected digital landscape, ensuring the security and integrity of critical infrastructure systems is more important than ever. The Critical Infrastructure Protection [...]
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 [...]
