AssurX Blog
Straight talk for regulated industries.
AssurX GDPR Compliance: Benefits and Lessons Learned
Proposed in 2012 and now in effect, the General Data Protection Regulation (GDPR) is the newest landmark of data protection legislation. GDPR compliance legislation is designed to bett [...]
Visit AssurX at the ASQ World Conference on Quality & Improvement (WCQI)
AssurX, a leader in quality management software systems, will exhibit at the 2018 ASQ World Conference on Quality & Improvement (WCQI). The event will be held in Seattle, Washingto [...]
Check Your Policy Management System Health
Policies and procedures tell your employees, partners, vendors, and customers how your system operates. With changing regulations and expectations, a static library is not enough. Poli [...]
Opinion: 3 Reasons to Consider SaaS for Quality Management Software
If you've been thinking about Software as a Service (SaaS) for your QMS and trying to justify the “why"—here’s a quick case supporting cloud QMS. Though not for everyone, it makes more [...]
2017 Recap: FDA Warning Letter Observations and Trends
In 2017, the FDA released 476 warning letters. Top FDA warning letter violations were (1) adulterated products, (2) misbranded products, (3) insanitary conditions and (4) unapproved ne [...]
How to Leverage an eQMS for Managing Product Adulteration
Recent FDA warning letters indicate that many drug manufacturers do not have manufacturing in a state of cGMP control. In the first half of 2017, the FDA cited adulterated products an [...]
