Pharmaceutical Manufacturing Compliance
Regulatory Compliance Challenge
A major pharmaceutical manufacturer faced increasing regulatory scrutiny and struggled with maintaining 21 CFR Part 11 compliance while managing complex batch production across multiple facilities.
Key Pain Points
- Complex FDA audit requirements consuming weeks of preparation
- Paper-based batch records prone to errors
- Difficulty tracking deviations and CAPAs
- Limited real-time visibility into production status
- Risk of data integrity issues
Blockchain-Verified Production
Tesan AI implemented a comprehensive digital manufacturing platform with WORM-compliant records and blockchain verification for complete data integrity.
Key Features Deployed
- Electronic batch records with WORM compliance
- Real-time production monitoring and alerting
- Automated deviation detection and escalation
- Blockchain-verified chain of custody
- AI-powered quality prediction
- Integrated CAPA management
Compliance Excellence
Measurable outcomes from the implementation
Implementation Journey
A structured approach to transformation
GxP Assessment
Validation of platform against 21 CFR Part 11 requirements
System Design
Custom configuration for pharmaceutical workflows
Validation
IQ/OQ/PQ protocols and documentation
Training
Comprehensive training for operators and quality team
Go-Live
Phased rollout with parallel operations
Use Cases Implemented
Specific applications within this implementation
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