Rekha pradeep N.

I help pharmaceutical, biotech, and regulated companies achieve compliant, audit-ready computerized systems through Computer System Validation (CSV), CSA, and 21 CFR Part 11 compliance support. With 15+ years of experience in GxP environments, I specialize in validating computerized systems aligned with 21 CFR Part 11, GAMP 5, GMP, and GCP requirements. I support clients across the full validation lifecycle — from planning and documentation to audit readiness — ensuring systems are compliant, inspection-ready, and aligned with regulatory expectations. 🔹 What I can help you with: ✔ Computer System Validation (CSV) & Computer Software Assurance (CSA) ✔ Validation lifecycle documentation (URS, FS, DS, IQ, OQ, PQ) ✔ 21 CFR Part 11 compliance & Data Integrity (ALCOA+) ✔ GAMP 5 risk-based validation approach ✔ Audit & inspection readiness (USFDA, MHRA, EMA) ✔ Periodic review & validation remediation ✔ SOPs, policies, and compliance documentation ✔ Vendor assessment & system qualification 🔹 Systems & Platforms Experience: Veeva, MasterControl, TrackWise, LIMS, QMS, eTMF, SAP, laboratory systems, clinical systems, and other GxP-regulated platforms. 🔹 What makes me different: ✔ Strong regulatory understanding with practical execution ✔ Inspection-ready documentation, not just theoretical deliverables ✔ Ability to quickly identify and resolve compliance gaps ✔ Clear communication and reliable delivery If you’re looking for a dependable CSV/CSA consultant who can support compliance, validation, and audit readiness with confidence, let’s connect. Keywords: CSV, CSA, GAMP 5, GMP, FDA, Validation, CAPA, SOP, IQ/OQ/PQ, Data Integrity, ALCOA+, Audit Readiness