Quality & Compliance
GMP compliance, regulatory frameworks, and audit readiness for bio-pharmaceutical AR.
Regulatory Compliance by Design
CRXR is architected from the ground up for GMP compliance in bio-pharmaceutical manufacturing environments. The platform implements comprehensive regulatory requirements including 21 CFR Part 11 electronic records, EU GMP Annex 1 sterile manufacturing controls, ICH Q10 quality system integration, and ISO 14644 cleanroom standards.
Regulatory Frameworks
21 CFR Part 11 (FDA)
United StatesKey Requirements
- •Electronic records authenticity and integrity
- •Electronic signatures with unique user identification
- •Audit trails for all record modifications
- •System validation and documentation
- •Secure access controls and user authentication
CRXR Implementation
CRXR implements 21 CFR Part 11 through cryptographic signatures, immutable audit logging, role-based access control validated through IQ/OQ protocols, and complete electronic batch record generation with timestamped operator actions.
EU GMP Annex 1 (2022 Revision)
European UnionKey Requirements
- •Contamination control strategy documentation
- •Environmental monitoring and trending
- •Operator qualification and competency
- •Critical process parameter control
- •Deviation investigation and CAPA
CRXR Implementation
CRXR AR guidance ensures contamination control through procedural adherence verification, integrates environmental sensor data for real-time monitoring, validates operator competency through performance tracking, and automates deviation documentation with root cause workflows.
ICH Q10 Pharmaceutical Quality System
InternationalKey Requirements
- •Quality risk management integration
- •Change control and impact assessment
- •Continuous improvement metrics
- •Knowledge management systems
- •Management review and oversight
CRXR Implementation
CRXR provides structured quality event capture, risk-based procedural guidance adaptation, performance trend analytics for continuous improvement, and executive dashboards for quality metrics review.
ISO 14644 Cleanroom Standards
InternationalKey Requirements
- •Cleanroom classification and monitoring
- •Contamination control verification
- •Equipment validation and qualification
- •Personnel training and gowning compliance
- •Environmental condition documentation
CRXR Implementation
CRXR integrates cleanroom environmental sensors (particle count, temperature, humidity, differential pressure) with AR-displayed alerts, validates gowning procedures through step-verification, and generates ISO 14644-compliant environmental monitoring reports.
Audit Readiness
Complete Audit Trails
Every operator action, system change, and procedural execution logged with cryptographic integrity verification
Audit Value:
Inspectors receive tamper-proof, timestamped records demonstrating GMP adherence
Electronic Batch Records
Automated batch record generation eliminating manual transcription and paper-based documentation
Audit Value:
Real-time batch record availability with instantaneous deviation flagging
Validated System State
IQ/OQ/PQ protocols with documented validation packages and change control integration
Audit Value:
Demonstrates system validation status and controls lifecycle throughout operation
Training and Competency Records
Automated operator competency tracking with performance-based requalification triggers
Audit Value:
Objective evidence of operator qualification and ongoing competency maintenance
Validation and Qualification
IQ - Installation Qualification
Hardware specification verification, network configuration validation, and environmental compatibility testing for clean-room deployment.
OQ - Operational Qualification
Functional testing of AR guidance accuracy, environmental sensor integration, and electronic signature workflows under operational conditions.
PQ - Performance Qualification
Operator performance validation, deviation rate measurement, and compliance documentation review under production conditions.