The challenge
A top 10 global pharmaceutical manufacturer wanted to move asset management and maintenance from a legacy system to IBM Maximo, integrated with TrackWise Digital, in a GxP-regulated environment.
GxP-critical Maximo workflows needed IQ/OQ/PQ validation. A large legacy data migration had to meet data integrity and audit trail requirements.
The system needed high availability with minimal planned downtime. Regulators expected traceable validation and compliant electronic signatures, while QA and IT resources were limited and deadlines were tight.
Our approach
- Used a CSA-aligned, AI-enhanced validation model with on-premise deployments of ChatGPT (OpenAI GPT-4) and Google Gemini.
- Predictive analytics with Gemini: analyzed legacy logs and past validation deviations to predict high-risk Maximo configurations and prioritize testing.
- Test case generation with ChatGPT: drafted IQ, OQ and PQ scripts from the URS, SOPs and Maximo configuration.
- Real-time anomaly detection during OQ, flagging permission mismatches, missing eSignatures and audit trail failures.
- Data integrity validation with Gemini: checked over 2 million legacy records for accuracy, completeness and Part 11 compliance before the final ETL.
- Documentation automation for traceability matrices, deviation logs and validation summary reports.
- Validated the AI tools as configurable utilities. SMEs reviewed all AI outputs, which were version-controlled under change control with audit trails.
- Aligned with 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5 and FDA's draft CSA guidance (2022).
Results
- 100% data integrity across migrated records.
- A fully traceable validation package aligned with regulatory expectations.
“We validated the AI just like any other critical system.”