Biotech & Pharmaceutical Monitoring
FDA 21 CFR Part 11 compliant environmental monitoring for pharmaceutical manufacturing, research labs, stability chambers, and cold storage facilities.
Comprehensive Monitoring for Pharma
ATEK provides end-to-end environmental monitoring solutions designed specifically for the pharmaceutical and biotechnology industries. Our platform ensures regulatory compliance while protecting your valuable products and research.
From stability chambers to cleanrooms, warehouses to cold storage, ATEK's wireless sensors and cloud platform deliver real-time visibility into your critical environments.
- FDA 21 CFR Part 11 compliant electronic records
- Comprehensive audit trails for all data changes
- Electronic signatures with authentication
- GAMP 5 validated documentation
- cGMP compliant workflows
- ICH Q1A stability study support
Applications
Monitoring solutions for every pharmaceutical environment
Stability Chambers
Monitor ICH stability studies with precise temperature and humidity control for drug development.
Cleanrooms
Track differential pressure, temperature, and particle counts in ISO classified environments.
Cold Storage
Protect biologics, vaccines, and temperature-sensitive compounds with real-time monitoring.
Warehouses
Ensure proper storage conditions across large-scale distribution facilities.
Frequently Asked Questions
How does ATEK support FDA 21 CFR Part 11 compliance?
ATEK's platform includes comprehensive audit trails, electronic signatures with authentication, user access controls, data integrity protections, and system validation documentation - all requirements of FDA 21 CFR Part 11 for electronic records.
Can ATEK monitor stability chambers for ICH studies?
Yes, ATEK provides precise temperature and humidity monitoring for stability chambers supporting ICH Q1A(R2) guidelines. Our sensors offer the accuracy and documentation required for regulatory submissions.
What alerts are available for pharmaceutical environments?
ATEK offers configurable alerts via SMS, email, and automated phone calls. You can set multiple thresholds, escalation paths, and acknowledgment requirements to ensure critical excursions are never missed.
Does ATEK provide validation documentation?
Yes, ATEK provides IQ/OQ/PQ documentation, GAMP 5 compliant system validation, and ongoing support for regulatory audits and inspections.
Protect Your Pharmaceutical Operations
Get a personalized demo and see how ATEK can help ensure compliance and protect your valuable products.