Controlytics meets the strictest pharmaceutical manufacturing standards and regulatory requirements globally.
Electronic records and signatures compliance. Our platform meets all FDA requirements for data integrity, audit trails, and secure authentication in pharmaceutical manufacturing environments.
European Medicines Agency validation requirements. Complete GAMP 5 compliance with computerized systems validation, data protection, and quality by design principles.
World Health Organization Good Manufacturing Practice standards. Ensures pharmaceutical products meet international quality and safety standards across global manufacturing facilities.
Accredited calibration and certification services. All monitoring equipment meets ISO 17025 standards with full traceability and audit documentation for regulatory inspections.
GDPR and industry-specific data protection. End-to-end encryption, role-based access control, and comprehensive data retention policies for sensitive pharmaceutical information.
Fully electronic batch documentation. Digital batch records with automated calculations, electronic signatures, and complete audit trails for traceability and recall management.
Comprehensive monitoring solutions designed for every critical pharma manufacturing process and environment.
Real-time particle counting, air quality, and cleanroom classification monitoring. Ensures ISO Class compliance and early detection of environmental deviations with automated alerts.
View Solution →Precise temperature measurement for controlled environments, stability chambers, and cold chain logistics. Accuracy to ±0.1°C with real-time graphing and deviation detection.
View Solution →Dual-parameter monitoring for storage conditions and manufacturing environments. Critical for stability testing, material storage, and manufacturing floor climate control.
View Solution →Monitor autoclave pressures, vacuum systems, and compressed gas lines. Ensures process validation, equipment safety, and regulatory compliance for critical manufacturing steps.
View Solution →Automated line clearance verification and electronic sign-offs. Prevents cross-contamination through digital validation and complete audit trails for product batch integrity.
View Solution →Monitor water systems, compressed air, steam, and power consumption. Critical utility monitoring ensures manufacturing continuity and energy efficiency tracking with quality assurance.
View Solution →Controlytics monitoring solutions address critical pharma manufacturing and storage scenarios.
Temperature monitoring for vaccine and biological storage with GPS tracking
ISO 14644 compliance with particle counting and air quality assurance
Temperature and pressure profiling for sterilization process validation
Climate control verification in pharmaceutical storage and distribution centers
Long-term temperature and humidity tracking for stability testing programs
Purified and WFI water quality monitoring with conductivity and temperature tracking
How a global pharmaceutical manufacturer improved compliance and reduced manufacturing downtime across five manufacturing facilities using Controlytics.
Challenge: A multinational pharmaceutical manufacturer with five manufacturing sites was struggling with manual environmental monitoring, inconsistent data collection across facilities, and delayed regulatory reporting. Compliance audits were exposing gaps in documentation and real-time deviation alerts.
Solution: Controlytics deployed a centralized monitoring platform across all five facilities with local sensors in cleanrooms, cold rooms, stability chambers, and utility systems. Real-time dashboards provided facility managers with immediate visibility into environmental parameters while automated alert systems notified operations teams of any deviations.
Results: The manufacturer achieved full FDA 21 CFR Part 11 compliance, reduced manual data entry by 90%, and enabled predictive maintenance through utility monitoring. Electronic batch records and digital line clearance eliminated cross-contamination incidents.
Enterprise-grade capabilities built specifically for pharmaceutical regulatory requirements and quality assurance.
Complete audit trails tracking every data point, modification, and user action. Immutable records meet FDA and EMA requirements for data integrity and accountability in manufacturing operations.
Secure digital signature functionality for batch approvals and critical manufacturing decisions. PKI-based signatures with encryption meet 21 CFR Part 11 and Annex 11 standards for authentication.
Configurable deviation alerts with escalation workflows. Real-time notifications to operations teams prevent manufacturing issues and enable immediate corrective actions within specified timeframes.
Automated calibration scheduling and ISO 17025 compliant tracking. Maintain instrument accuracy with calibration certificates, traceability documentation, and NIST correlation for all sensors.
Advanced statistical analysis and automated regulatory reports. Generate FDA-compliant summaries, trending analysis, and deviation reports for inspections and quality reviews.
Centralized monitoring across multiple manufacturing facilities. Unified dashboards, consolidated reporting, and global compliance visibility while maintaining site-specific access controls and data segregation.
Schedule a demonstration to see how Controlytics ensures regulatory compliance and manufacturing excellence.