Batch Record Automation for Pharmaceutical Manufacturing
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Pharmaceutical Compliance Guide
Key Production Challenges
Paper-based Batch Manufacturing Records
Impact: Slow batch release, manual data entry errors, and compliance delays in high-volume production.
Manual eBMR Review
Impact: Delays in batch release and high compliance risk due to time-consuming manual reviews.
Unplanned Equipment Downtime
Impact: Disrupted production schedules, lost revenue, and batch failures.
Inconsistent Review Standards
Impact: Variability across reviewers leading to missed deviations and audit findings.
Electronic Batch Records (eBMR)
GenAI-Enabled Batch Record Management
A multi-site dosage manufacturer experienced prolonged batch release timelines due to manual, paper-intensive BMR review. Quality teams spent days reviewing each batch record, often missing critical deviations buried in pages of documentation.
Many pharmaceutical companies still rely on paper batch records, creating bottlenecks in batch release and increasing compliance risk. Our document digitization services convert these paper records into searchable digital formats, enabling AI-powered review and faster batch release.
- AI-based digitization of paper BMRs, logbooks, and IPC records
- Real-time error and deviation detection during batch execution
- Automated review-by-exception using GenAI reasoning
- FDA 21 CFR Part 11 compliant electronic signatures
- Batch genealogy and traceability tracking
- Automated cross-referencing against SOPs and master batch records
- Complete audit trail for FDA inspections
Business Impact
Automated review-by-exception focuses human attention only where needed
Real-time deviation detection and automated cross-referencing
Consistent and standardized reviews across all products
Maintenance Intelligence
Predict failures weeks in advance with ML models
Proactive maintenance based on actual equipment condition
AI process drift detection and optimization recommendations
Predictive Equipment Maintenance
AI-Driven Equipment Health Monitoring
Critical production equipment failures were causing unplanned downtime and batch losses. Reactive maintenance approaches meant equipment failures were only addressed after they occurred, disrupting production schedules and causing significant revenue loss.
Our IoT-enabled predictive maintenance solution analyzes real-time sensor data to predict equipment failures before they occur. Historical maintenance records stored in our records management system provide the data foundation for accurate predictions.
- Real-time sensor data analysis from production equipment
- Machine learning models for failure prediction weeks in advance
- Maintenance scheduling optimization based on equipment health
- Equipment health dashboards and automated alerts
- Integration with CMMS systems for work order generation
- Spare parts inventory optimization
Built for Regulatory Compliance
Our batch record automation solutions are designed to meet the stringent requirements of pharmaceutical manufacturing
Electronic Records & Signatures with complete audit trails
Computerised Systems validation and compliance
Data Integrity Principles ensuring data quality
Risk-Based Validation framework
Ready to Automate Your Batch Records?
See how our eBMR solution can accelerate batch release while maintaining strict FDA compliance.
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