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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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) misb [...]
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. I [...]
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 [...]
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 the [...]
EQMS Solutions are Not One-Size-Fits-All
Software as a Service (SaaS), otherwise known as cloud-based computing, has become a widely accepted concept. Even the E [...]
AssurX Announces Corporate-Wide HIPAA Compliance
Morgan Hill, CA – November 2, 2017 - AssurX, Inc., a leading provider of enterprise quality management and regulatory co [...]
