FDA 21 CFR Part 11
Electronic records and signatures compliance with complete audit trails and access controls.
Pharmaceutical Compliance & Safety Intelligence
Ensure GMP compliance, monitor cleanroom environments, and maintain regulatory audit readiness with AI-powered pharmaceutical and chemical plant operations intelligence.
See Pharma Solutions →Built for Regulatory Excellence
Compliant with global pharmaceutical and chemical industry standards—with audit-ready evidence at every step.
EU GMP Annex 11
Computerized systems validation with documented change control and disaster recovery.
ISO 13485
Quality management systems for medical device manufacturing with full traceability.
ICH Q7 / Q10
Good manufacturing practices for active pharmaceutical ingredients and quality systems.
OSHA PSM
Process safety management for highly hazardous chemicals with incident prevention.
Data Integrity (ALCOA+)
Attributable, legible, contemporaneous, original, and accurate data management principles.
Pharma & Chemical Use Cases
AI-powered capabilities tailored for your industry
Pharma & Chemical
GMP Compliance Monitoring
Automated monitoring of manufacturing practices, personnel hygiene, and environmental conditions with real-time compliance alerts and documentation.
Pharma & Chemical
Cleanroom Management
Monitor personnel gowning procedures, particle counts, temperature/humidity levels, and access control in classified clean areas.
Pharma & Chemical
Chemical Storage Safety
AI-powered hazard detection, spillage alerts, incompatible chemical proximity warnings, and emergency response coordination.
Pharma & Chemical
Batch Traceability
End-to-end tracking of raw materials, intermediates, and finished products with complete audit trails for regulatory compliance.
Pharma & Chemical
Equipment Integrity
Predictive maintenance for critical equipment like reactors, autoclaves, and mixing vessels with regulatory-compliant documentation.
Pharma & Chemical
Regulatory Audit Trails
Automated generation of comprehensive audit trails for FDA, EMA, and other regulatory inspections with timestamped evidence.
Leading Pharma Manufacturer Success Story
“We passed our FDA inspection with zero 483 observations. Variphi's automated audit trails gave us complete confidence and saved our QA team 35 hours every week.”
The Challenge
Manual GMP documentation taking 40+ hours per week. Cleanroom violations discovered only during quarterly audits. No real-time visibility across 12 production lines and 8 cleanrooms.
The Solution
Deployed Variphi Vision Intelligence for automated compliance monitoring, cleanroom surveillance, and real-time audit trail generation integrated with existing QMS and MES.
Measurable Impact
92% Less Documentation Time
₹6.8 Cr Annual Savings
Zero Audit Findings
98.7% Compliance Score