Computer Systems Validation

Independent Solutions provide full System Life-Cycle (SLC) validation for computer systems ranging from small systems to large-scale (Enterprise Resource Planning) systems in accordance with site requirements, GAMP, FDA & EU standards. This involves the development & execution (where applicable) of the following documentation:

  • Regulatory Assessment

  • Project Scope

  • Validation Project Plan (VPP)

  • User Requirements Specification (URS)

  • Functional Specification (FS)

  • Functional Design Specification (FDS)

  • Hardware Design Specification (HDS)

  • Configuration Specifications (CS)

  • Risk Assessments

  • Part 11 Compliance Assessment

  • Factory Acceptance Test (FAT)

  • Site Acceptance Test (SAT)

  • Supplier Auditing

  • Installation Qualification (IQ) protocols and Reports

  • Operational Qualification (OQ) protocols and Reports

  • Performance Qualification (PQ) protocols and Reports

  • Performance Monitoring Protocol

  • Requirements Traceability Matrix (RTM)

  • Validation Summary Report

  • Computer Systems Decommissioning

  • SOP development

  • Disaster Recovery Plan

  • Business Continuity Plan

  • Periodic Review

  • Training Plans

Examples of Computer System Validation

  • Chromatography Systems

  • Labelling Systems

  • ERP Systems

  • Laboratory Systems

  • Calibration Systems