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Root Cause Analysis as a Tool for CAPAs

September 12th, 2014 by

CAPA Root Cause AnalysisCAPAs, or Corrective and Preventive Actions, are largely designed to help GxP-regulated firms handle non-conformity problems. In order to deal with undesirable occurrences in manufacturing processes, [...] 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

What Goes into CSV Compliance?  

September 5th, 2014 by

Computer System ValidationMost of the more complex computer systems employed by life-sciences firms are in some way customized. Even those who rely on vendor-assembled systems often find themselves having to tweak [...] Read More

Harmonization Processes Through ICH  

September 3rd, 2014 by

ICH Harmonization ProcessThe methodologies your firm employs in the creation of pharmaceuticals, medicines and similar products designed for human consumption are most likely unique. Even if you follow relatively [...] Read More