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GUERRA
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Contact Johnny Guerra, former FDA Computer Specialist, to support your CSV and Data Integrity efforts.
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.
Prevent regulatory fines and financial losses. Ensure that your CSV activities are in compliance with all applicable statutory and FDA regulatory requirements.
FDA CSV & Part 11 Compliance
Computer System
Validation (CSV)
GCGI’s CSV Manufacturing and Laboratory Services include the following:
“Established since 1999”
REGULATORY COMPLIANCE SERVICES
Get Certified in CSV!
See GCGI’s
CSV CERTIFICATION PROGRAM. ™
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