AssurX Blog
Straight talk for regulated industries.
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 comp [...]
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 [...]
Remote Quality Audits for Regulated Companies Come of Age
This article is part one of a two-part series focused on GMP quality audit management. Although quality audits are traditionally on-site, many regulated companies have experience with [...]
How to Conduct Remote Supplier Quality Audits in a QMS
Since the Covid pandemic, regulators and notified bodies have been doing more remote audits to conduct routine inspections. In fact, it helped the FDA exceed domestic inspections in FY [...]
