Learn How To Think Like The FDA ®
The use of manufacturing and laboratory computerized systems generating source data must meet fundamental elements of data quality (attributable, legible, contemporaneous, original and accurate) that is expected of paper records per cGMP regulations as enforced by US Food and Drug Administration (FDA).
Johnny Guerra, a former FDA Computer Specialist, ensures that GCGI’s Consulting, Auditing, Training and Validation services are executed in compliance with all applicable statutory and FDA regulatory requirements.
Guerra’s knowledge, skills and abilities to detect the quality and integrity of data during CSV audits and validation activities has saved firms from millions of dollars in regulatory fines and financial losses.
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REGULATORY COMPLIANCE SERVICES