Gofaone Rantsimele

Gofaone Rantsimele is a Computer System Validation (CSV) Engineer with over 9 years of experience in the pharmaceutical, biotech, and medtech industries. Specializing in GxP compliance, IT qualification, and data integrity, Rantsimele ensures regulatory adherence for systems like LIMS, SAP, and MES. Their expertise spans FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 standards, with a focus on risk-based validation, digital transformation, and operational readiness. Rantsimele has delivered qualification for over 15 IT infrastructure components and authored 45+ validation deliverables with zero major audit findings. They are certified in ISO 9001, 13485, 14001, and 27001, and are an active ISPE member.