Vinoth Ramakrishna

Senior Computer System Validation (CSV) Engineer | GxP | FDA 21 CFR Part 11 | GAMP 5 | Data Integrity

McPherson

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Skills

21 CFR Part 11
EU Annex 11
GxP (GMP, GLP, GDP)
FDA-regulated environments
Data Integrity (ALCOA+)
Electronic Records & Electronic Signatures (ERES)
Audit readiness & inspection support
Change Control & CAPA processes