Dr. Simone Peschl Named GxP-CC Operations Manager

December 12th, 2014 by

GxP-CC Hires Dr. Simone Peschl[...] Read More

What Role Will Supplier Audits Play in Your Supply Chain’s Integrity?

December 2nd, 2014 by

Supplier AuditsWhere’s the weakest link in [...] Read More

What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by

FDA Warning Letter Form 483 Response[...] Read More

Understanding the Results of FDA Gap Analysis

October 14th, 2014 by

FDA Gap AnalysisFDA gap analysis helps organizations [...] Read More

Validated Cloud Computing in Today’s Regulated Environments

October 10th, 2014 by

FDA Cloud Computing Validation[...] Read More

Are You Ready to Become Compliant With EU Annex 11?

October 8th, 2014 by

EU Annex 11Compliance[...] Read More

Getting to Know FDA Software Validation Principles

October 3rd, 2014 by

FDA Software ValidationHow [...] Read More

Root Cause Analysis as a Tool for CAPAs

September 12th, 2014 by

CAPA Root Cause AnalysisCAPAs, or Corrective and Preventive Actions, [...] Read More

The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by

Electronic SignaturesRegulatory [...] Read More

What Goes into CSV Compliance?  

September 5th, 2014 by

Computer System ValidationMost of the more [...] Read More