Excel-Based LIMS Development and Computer System Validation (CSV)

Project Overview Developed an Excel-based Laboratory Information Management System (LIMS) and performed Computer System Validation (CSV) following GAMP 5 principles.

• Key Features :

• Sample Registration

• Analyst Assignment

• Result Entry & Reporting

• Data Traceability

  • Validation Deliverables :

• User Requirements Specification (URS)

• Risk Assessment

• Installation Qualification (IQ)

• Operational Qualification (OQ)

• Requirements Traceability Matrix (RTM)

• Validation Summary Report (VSR)

  • Compliance :

• GAMP 5

• 21 CFR Part 11

• EU Annex 11

• ALCOA+ Principles

• Skills demonstrated :

• Computer System Validation (CSV)
• GAMP 5 Methodology
• User Requirements Specification (URS)
• Risk Assessment
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Requirements Traceability Matrix (RTM)
• Validation Summary Report (VSR)
• Data Integrity (ALCOA+)
• Excel Spreadsheet Validation