AssurX Blog
Straight talk for regulated industries.
What is a Quality Management Review and Why Do You Need Them?
This is the first installment of a two-part series focusing on the importance of a quality management review for companies in regulated industries. What is a quality management review [...]
Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with ISO 13485:2016 was long in coming, but worth the wait. Regulatory authorities consider it necessary to imp [...]
FDA Warning Letters Highlight Food Safety Compliance Issues
The U.S. Food and Drug Administration (FDA) has issued dozens of warning letters to date in 2022, also announcing resumed inspections after pausing them amid the Omicron surge. Further [...]
miraDry Implements AssurX Quality Management and Regulatory Compliance Software
MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leader in quality management software and regulatory compliance software, announced today that miraDry®, a lea [...]
How an EQMS can Reduce CAPA and Complaint Observation Trends
As we move through 2022, we look forward to new opportunities, new challenges, and a return to normal. Unfortunately, one thing that won’t change is the likelihood of FDA CAPA and com [...]
5 Tips for Turning GMP Audits from an Adversarial to a Cooperative Process
This article is part two of a two-part series focused on GMP quality audit management. The very concept of an audit puts auditors on one side and auditees on the opposite side. This is [...]
