Elvis is a Senior Validation, Computerized Systems Validation (CSV), and Laboratory Systems Consultant with more than 15 years of experience supporting GMP‑regulated pharmaceutical manufacturing and laboratory environments. He provides end‑to‑end validation and compliance support across laboratory, manufacturing, automation, and enterprise systems, aligned with 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity (ALCOA+) requirements.
Elvis has extensive hands‑on experience leading and executing equipment, facility, utility, and computerized system validation, including IQ/OQ/PQ, risk‑based validation strategies, and lifecycle governance. He is highly experienced in administering and validating GxP laboratory systems, including LIMS, ELN, CDS, and instrument‑integrated applications, supporting system implementation, configuration oversight, user and role management, change control, periodic review, incident management, disaster recovery, and system decommissioning.
He is a trusted subject matter expert during FDA and global regulatory inspections, with a strong record of authoring and maintaining Validation Master Plans (VMPs), SOPs, and validation deliverables. Elvis partners closely with Quality, Engineering, IT, Laboratory Operations, and Manufacturing to maintain inspection readiness and a sustained validated state in highly regulated environments.
