GMP-compliant documentation
Part 11 compliant records
Batch rejections from environment
Continuous monitoring & alerts
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Strict FDA 21 CFR Part 11 and EU GMP Annex 11 requiring continuous, tamper-proof documentation
Cleanroom deviations compromising sterile manufacturing conditions
Cold storage excursions for temperature-sensitive APIs and biologics — each batch worth $100K+
Manual monitoring creating documentation gaps and increasing audit risk
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Cleanroom Environmental Monitoring
Connect 2.0 sensors monitor temperature, humidity, and differential pressure in ISO-classified cleanrooms — with configurable alerts and automatic escalation.
Cold Storage & Stability Validation
Wireless temperature monitoring in refrigerated storage (2-8°C), freezers (-20°C), and ultra-cold units (-80°C) — with automated deviation reports.
Automated Compliance Documentation
Every reading captured with timestamps and full audit trail in Retina. Generate batch records, deviation reports, and compliance exports on demand.