AssurX Blog
Straight talk for regulated industries.
All Roads Lead to ISO 13485: The Global Context
As regulations and standards evolve, one trend is continually sharpening in focus. ISO 13485 for medical device quality management systems is becoming the international standard for s [...]
Are FDA Warning Letters and 483 Observations About to Spike?
The number of U.S. Food and Drug Administration (FDA) inspections dropped dramatically in 2020, with the agency postponing most onsite visits to limit COVID-19 risks. The number of FD [...]
Supplier Quality Management: A New QMS-Based Approach
According to research firm LNS Research, fewer than 1 in 5 companies have a robust supplier quality management process. Even more revealing, those that do enjoy a 16 percent lower cost [...]
Elements of an Effective Supplier Scorecard
Imagine if your plant is starting work on a big order. You’ve just been advised that a supplier has placed a key material on backorder. To fulfill the contract with your customer, you’ [...]
5 Quality Management Trends to Watch in 2021
2020 represented the sharpest economic slowdown in modern history. Nonetheless, with manufacturing orders reaching a three-year high in February 2021, according to the Institute of Sup [...]
Computer Systems Assurance: Making the Transition from Computer Systems Validation
For decades, pharmaceutical and medical device companies have operated under the assumption that they must document and validate each and every software used in their processes. The co [...]
