Reducing CSV Time Using AI-Powered Predictive Analytics During Maximo Implementation

Solution: AI-Driven Validation and Predictive Compliance

SQA Solution introduced a CSA-aligned, AI-enhanced validation model using on-premise deployments of ChatGPT (OpenAI GPT-4) and Google Gemini. This architecture ensured control, data privacy, and GxP auditability. By leveraging AI in test design, data integrity assurance, and documentation automation, the company accelerated validation and mitigated compliance risk.

AI Integration across CSV & CSA Activities

1. Predictive Analytics (Gemini):
   
   • Analyzed legacy system logs and previous validation deviations
     
   • Predicted high-risk configuration scenarios in Maximo
     
   • Informed test prioritization under CSA principles
     
2. Test Case Generation (ChatGPT):
   
   • Generated IQ, OQ, PQ test scripts based on URS, SOPs, and Maximo configuration
     
   • Reduced writing time and ensured alignment with validation templates
     
3. Real-Time Anomaly Detection:
   
   • Flagged OQ issues such as permission mismatches, missing eSignatures, and audit trail failures
4. Data Integrity Validation:
   
   • Gemini validated 2M+ legacy records for accuracy, completeness, and Part 11 compliance
     
   • Detected 92% of field-level anomalies before final ETL
     
5. Documentation Automation:
   
   • AI generated traceability matrices, deviation logs, validation summary reports
     
   • Ensured full GAMP 5 and SOP alignment
     

Implementation Timeline

• Weeks 1–4: CSA planning, AI deployment, SOP ingestion, risk assessment
• Weeks 5–8: URS finalization, data profiling, and dry-run migration with predictive QA checks
• Weeks 9–12: AI-driven test case generation and approval workflows
• Weeks 13–16: IQ/OQ/PQ execution with AI-assisted scripts and real-time Gemini alerts
• Weeks 17–20: Final documentation, stakeholder signoffs, and validation summary reports
• Week 21: Go-live with zero critical validation issues

Results & Measurable Impact

• 30% CSV timeline reduction (from 10 to 7 weeks)
  
• 40% reduction in manual test case authoring
  
• 100% data integrity across migrated records
  
• 0 critical post-deployment incidents or audit findings
• Fully traceable validation package aligned with regulatory expectations

Regulatory Alignment & Governance

The AI-assisted validation strategy aligned with:

• FDA 21 CFR Part 11 (Electronic Records; Electronic Signatures)
• EU GMP Annex 11 (Computerised Systems)
• ISPE GAMP 5 (Risk-Based Approach)
• ISPE GAMP Good Practice Guides (Data Integrity by Design, Testing)
• FDA Draft CSA Guidance (2022)

All AI outputs were reviewed by SMEs, version-controlled, and governed via documented change control. AI tools were validated as configurable utilities, and all artifacts were fully audit-trail enabled.