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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 SaaS. Though not for everyone, it certainly [...]

When a change management system is designed effectively, it defines how strategies, procedures and technologies will be applied to address changes in the business environment. Implementing a [...]

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 [...]