Hashim Shaikh

Senior Computer System Validation (CSV) Consultant with 11+ years of experience supporting pharmaceutical, biotechnology, and regulated industries. Proven expertise in Computerized System Validation (CSV), GAMP 5, 21 CFR Part 11, EU Annex 11, Data Integrity, and GxP compliance. Extensive experience in end-to-end validation lifecycle management, including Validation Plans (VP), User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Risk Assessments (RA), IQ/OQ/PQ Protocols, Traceability Matrices, Validation Reports, SOP development, periodic reviews, and audit support. Key expertise includes: • SAP S/4HANA Validation (Greenfield and Bluefield implementations) • SAP ECC and SAP modules (MM, PP, QM, SD, PM, WM, FI/CO) • LIMS, ELN, TrackWise, Salesforce, Empower, LabSolutions • Cloud and On-Premise System Validation • Vendor Audits and Supplier Qualification • Computer System Validation Strategy Development • Regulatory Compliance Assessments • Data Integrity and Quality Management Systems Successfully delivered validation projects for leading global organizations across pharmaceutical and life sciences sectors, including SAP implementations, laboratory systems, quality management platforms, and enterprise applications. I help clients achieve regulatory compliance, maintain inspection readiness, and implement risk-based validation approaches while ensuring systems remain compliant, efficient, and audit-ready. Available for: ✔ Computer System Validation (CSV) ✔ SAP Validation ✔ GAMP 5 Compliance Consulting ✔ 21 CFR Part 11 Assessments ✔ Validation Documentation Authoring & Review ✔ Audit Readiness & Remediation ✔ SOP Development & Quality Documentation ✔ Vendor/Supplier Audits ✔ Data Integrity Assessments