Of the FDA's Top 10 Observations in 503B Pharmacies, the second most common observation (69.8%) of was:
"Aseptic processing areas are deficient regarding the system for monitoring environmental conditions."
Reduce the risk of lost product and regulatory non-compliance in your hospital pharmacy environments, ORs, procedure rooms, blood and tissue banks, and labs.
- Watch a system overview video
- See a Device Selection Guide
- View our Library of GxP Regulatory Articles
The Vaisala viewLinc continuous monitoring system is ideal for Medical Temperature monitoring application and offers:
- Easy-to-use viewLinc software allows effortless monitoring, reporting and alarm management
- 24/7 remote alarming via SMS, e-mail, pager and many more to reduce the risk of lost products
- Custom reports that are automatically generated and delivered by email on demand
- Fast and easy IQOQ validation and on-site installation services for smooth start-up and higher productivity (Sample IQOQ)
- Low cost-of-ownership due to easy connectivity to your existing network, remote access, and scalability up to thousands of monitored locations
- Vaisala also offers a wide range of hand-held humidity and temperature meters for spot-checking and on-site transmitter calibrations
- Vaisala's H2O2 sensors are the ideal solution for environmentally safe bio-decontamination
- Parallel monitoring and alarming for critical medical environments, liquid nitrogen tanks, sample storage, pharmacy compounding areas
"Of all the monitoring systems we looked at, the viewLinc monitoring system provided the best value ... hands down!"
- Dorraine Reynolds, Pharmacy Director US-based National Research Hospital
Monitoring System Features
- Gap-free data recording with complete audit trail.
- Battery-powered data loggers function up to 10 years and have large on-board memory for immunity to network failures and power outages.
- Remote alarming via SMS, email, flashing PC alert, and other alerting mechanisms.
- Fast, simple installation and validation - with our IQOQ documents or validation service.
- Scalable from one to thousands of monitored points.
- Software and devices were designed to ensure you comply with Part 11 and Annex 11 requirements.
- Saves on IT and installation costs by connecting easily to any standard network via Ethernet, Power over Ethernet, wireless, or Wi-Fi.
Vaisala’s monitoring solutions are designed for accuracy, reliability and compliance with regulatory regimes. With sensors for temperature, humidity, differential pressure, CO2, vaporized H2O2 and other parameters, monitoring healthcare facilities is simple. With viewLinc browser-based software or easy user interfaces like Indigo transmitters, it’s easy to ensure that conditions are maintained.
Australia’s Leading Pharmacy Service Provider Safeguards Products with Gap-Free Data & Fail-Safe Alarming
Five Reasons to Increase Temperature Monitoring Probes: increasing space, product price or sensitivity, temperature differential, & cooling system reliability
In this application note, we classify the common issues in multi-site environmental monitoring systems into five broad types: Security, Administration, Geographic Variation, Multiple Site Types, and IT Infrastructure. We outline how the Vaisala viewLinc monitoring system handles these challenges in three GxP-regulated application types: warehouses, global manufacturing operations, and regional hospitals and healthcare facilities.
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