AssurX Blog
Straight talk for regulated industries.
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 and [...]
Leveraging a Quality Management System to Do More
What provides more value in a quality management software purchase—a single-use system, or one that can be leveraged for multiple purposes? This seems like an obvious answer, except th [...]
The Importance of Documenting Enterprise QMS Process Requirements
You’re in the market to build a new house. Would you tell the builder what you’re looking for or would you just tell them to build “something”? If the latter, what’s the likelihood tha [...]
