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Understanding the Results of FDA Gap Analysis

October 14th, 2014 by

FDA Gap AnalysisFDA gap analysis helps organizations quantify the differences between their real-world operations and the compliance rules that govern them. For instance, regulated firms commonly [...] Read More

Validated Cloud Computing in Today’s Regulated Environments

October 10th, 2014 by

FDA Cloud Computing ValidationAdopting cloud-based technologies is a common step for [...] Read More

Are You Ready to Become Compliant With EU Annex 11?

October 8th, 2014 by

EU Annex 11ComplianceIf you engage in GMP-regulated actions, use computers in any facility and wish to market your products in the EU, you’ll need to become familiar with EU [...] Read More

Getting to Know FDA Software Validation Principles

October 3rd, 2014 by

FDA Software ValidationHow can your firm validate its software effectively when it’s such an integral part of everything you do? Today’s GxP-regulated organizations employ software for stock tracking, supply chain [...] Read More