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

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by

Electronic SignaturesRegulatory compliance is important for any life-sciences firm, but the breadth of your responsibilities won’t always be immediately clear. For instance, you may be well aware of the fact that 21 CFR Part 11 [...] Read More

Instituting Effective FDA Gap Analysis Policies

April 25th, 2014 by

FDA Gap Analysis ComplianceWhen GxP firms take actions to maintain compliance with recommendations from the FDA and the EU, it’s critical that they actually analyze the results after the fact. Failing to assess your compliance implementations effectively and on a periodic basis could [...] Read More