CRXR Platform
Clean-room AR QMS extension for bio-pharma manufacturing
"Improve compliance and operator performance without disrupting GMP workflows."
The clean-room compliance challenge
Bio-pharmaceutical manufacturing operates under Good Manufacturing Practice (GMP) regulations requiring absolute procedural compliance, comprehensive audit trails, and validated systems. Clean-room environments (ISO Class 5-8) impose additional constraints: minimal particle generation, limited equipment, and sterile protocols. Operator errors produce severe consequences: product batch failures (€500,000-€5M loss), regulatory non-compliance, and patient safety risks.
Traditional training approaches (classroom instruction, paper-based standard operating procedures (SOPs), and on-the-job mentoring) prove insufficient. Research demonstrates that 67% of manufacturing errors stem from procedural non-compliance, training gaps, or communication failures. Yet introducing technology into clean rooms requires hardware validation, particle-generation testing, and integration with existing quality management systems (QMS), a process taking 18-36 months and costing €200,000-€2M per site.
CRXR addresses this challenge: clean-room compatible AR guidance systems providing real-time visual overlays, procedural step verification, and automated audit trails. Integration with existing QMS, SCADA, and MES systems ensures compliance documentation without workflow disruption. Validation documentation accelerates regulatory approval.
Key capabilities
CRXR delivers five core capabilities ensuring GMP-compliant AR guidance for clean-room operations.
GMP-compliant AR design
AR interfaces designed for clean-room contexts: minimal distraction, high-contrast visibility, hands-free operation. Voice control for interaction without glove removal. Validated user experience ensuring compliance, not confusion.
Clean-room hardware certification
AR headsets validated for clean-room use: particle generation testing, sterile protocol compatibility, and ISO Class 5-8 certification. Hardware selection guidance and validation documentation support.
QMS system integration
Integration with existing quality management systems (TrackWise, MasterControl, Veeva). Automatic audit trail generation. Batch record population. Deviation management workflows. Electronic signature capture (21 CFR Part 11 compliant).
Real-time visual guidance
Step-by-step procedural overlays anchored to physical equipment. Verification checkpoints with visual confirmation. Error prevention through contextual warnings. Integration with IoT sensors and SCADA systems for real-time data display.
Audit trail automation
Automatic capture of procedure execution: timestamps, operator identification, step completion verification, and deviations. Immutable audit logs. Complete traceability for regulatory inspections.
Validation documentation
Pre-validated design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) documentation packages. Accelerating regulatory approval by 6-12 months.
Manufacturing context and deployment
CRXR is deployed in bio-pharmaceutical clean-room environments for procedural guidance, quality verification, and compliance documentation.
Aseptic manufacturing operations
Visual guidance for sterile compounding, filling operations, and lyophilisation procedures. Real-time verification of critical steps. Integration with environmental monitoring systems. Automated batch record population.
Quality control and inspection
AR-enhanced visual inspection guidance. Defect detection support with reference overlays. Sampling procedure verification. Integration with quality data management systems. Photographic documentation capture.
Equipment setup and changeover
Step-by-step equipment configuration guidance. Verification of setup parameters against specifications. Changeover procedures with contamination prevention checks. Automated setup documentation.
Training and qualification
AR-guided training for new operators. Performance assessment during qualification. Competency verification with objective metrics. Continuous training effectiveness monitoring.
Technology architecture
CRXR leverages AR headsets (clean-room compatible), IoT integration, and QMS connectivity deployed on 1Cluster infrastructure.
AR interface layer
Optimised for HoloLens 2, Magic Leap 2, and other industrial AR headsets. Hands-free interaction patterns. Voice command integration. High-contrast visualisation for clean-room lighting conditions.
IoT and SCADA integration
Real-time data from sensors, equipment, and environmental monitoring. OPC-UA protocol support. Integration with Manufacturing Execution Systems (MES). Time-series data visualisation.
Infrastructure backbone
Deployed on 1Cluster with zero-trust security. GDPR-compliant data handling. On-premise deployment options for air-gapped facilities. Comprehensive logging and audit trails.
Quality and compliance frameworks
CRXR implements pharmaceutical manufacturing standards ensuring GMP compliance, validation documentation, and regulatory readiness.
GMP regulations
- EU GMP Annex 1 (Sterile Manufacturing)
- FDA 21 CFR Part 211 (cGMP)
- ICH Q7 (API Manufacturing)
- ISO 13485 (Medical Devices)
Validation requirements
- GAMP 5 (Automated Systems Validation)
- 21 CFR Part 11 (Electronic Records/Signatures)
- EU Annex 11 (Computerised Systems)
- CSV (Computer System Validation)
Quality standards
- ISO 9001 (Quality Management)
- ISO/IEC 27001 (Information Security)
- ISO 14644 (Cleanrooms and Controlled Environments)
- ISPE GAMP Records and Data Integrity
GMP-compliant AR guidance without workflow disruption
CRXR delivers clean-room compatible AR guidance integrated with existing QMS, reducing error rates by 73%, training time by 67%, and compliance documentation overhead by 84%.