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Computer System Validation
PLC | HMI | SCADA Onsite Validation
21 CFR Part 11 | Annex 11 Compliance Auditing, Gap Analysis and Recommendation Report
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Cloud and IT System Validation Support
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COMPUTER SYSTEM
VALIDATION
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 21CFR Part 11 Assessment Checklist (ERES)
Development of Validation Summary Report (VSR)
COMPUTER SYSTEM
VALIDATION
DOCUMENTATION
