Computerized System Validation (CSV) ensures that computer systems used in regulated industries operate with accuracy, reliability, and compliance to industry standards and regulatory guidelines. It covers the full lifecycle of computerized systems—hardware, software, networks, and controlled functions—ensuring they meet GxP compliance and 21 CFR Part 11 requirements.

Arizona provides end-to-end CSV services, validation deliverables, and training to help organizations maintain regulatory compliance and operational excellence.

PLC, HMI, IPC, SCADA, DCA System Validation

HPLC, GC, FTIR, Spectrometer, EMPOWER, UV, LCMS-MS, Chromeleon, SAS, WinOnlin & more

SaaS, SAP, ERP, MES, LIMS, TMS, QMS, E-DMS

Comprehensive validation of BMS & EMS systems

Cloud, Server, Network Validation, Meta Data Qualification, Desktop Validation

Track & Trace, TracLINK, ReeTrak, L1–L5 Integration Validation, Warehouse Management Software Validation

Excel Sheet Validation (21 CFR Part 11 compliant)

Audit Support, CSV Audit & Training

✔ GxP Assessment & System Categorization

✔ Validation Plan

✔ User Requirement Specifications (URS)

✔ Risk Assessment

✔ Functional Design Specification (FDS)

✔ Installation Qualification (IQ)

✔ Operational Qualification (OQ)

✔ Performance Qualification (PQ)

✔ Validation Summary Report

✔ Traceability Matrix

✔ System Release Certificate

✔ Periodic Review Report

✔ GAP, GxP & 21 CFR Part 11 Assessment

✔ Validation Framework

✔ Risk-based approach

✔ Lifecycle-based approach

✔ “V”-Model for development & system testing

✔ Process-based validation

✔ GAMP5 category system approach

✔ Validation plans and reports follow a disciplined, consistent methodology to ensure compliance, accuracy, and reliability.

Administration | Quality Unit | Investigation | Development | Manufacturing | Laboratory | Engineering | Maintenance | Regulatory Affairs | Human Resources | IT | Support Staff | Suppliers