Validation Services

Enhancing compliance through system and software validation

21 CFR Part 11 | Annex 11 Compliance Auditing, Gap Analysis and Recommendation Report
Lab Instrument Software Validation
BMS | EMS | LIMS | SAP | ERP | MES Validation
Cloud and IT System Validation Support
Excel Sheet Validation
Backup and Recovery Plans
Configuration Management
Supplier Audit Assistance

Validation Documentation Package
Development of Computer System Validation Master Plan (CS-VMP)
Development of Initial Risk Assessment (IRA)
Development of Functional Risk Assessment (FRA)
Development of Installation Qualification (including screen shots)
Development of Operational Qualification (including screen shots)
Development of Performance Qualification (including screen shots)
Development of Validation Traceability Matrix
Development of 21 CFR Part 11 Assessment Checklist (ERES)
Development of Validation Summary Report (VSR)