Mesa Labs is dedicated to helping our customers find the most appropriate solution to the challenges they face. One of our clients, Providence Portland Medical Center, based in Portland, Oregon, had previously experienced detrimental product loss. By utilizing Mesa’s AmegaView monitoring system, the medical center was able to be notified immediately and prevent future product…Details
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Wireless, Hardwired & Hybrid Monitoring Solutions
What We Monitor
- Temperature (TMP)
- Differential Pressure
- Open/close Alarm
- Air Velocity
- Power Line
- Door Switches
- Particle counters
How We Monitor:
- ISO 17025 compliant
- 21 CFR Part 11
- Quality Control
- Floor Plans
- Customized Alarming
- Alarm Escalation
- Disaster Recovery
- Automated Reporting
- Graphical Reports
- Audit Assistance
Dedicated Project Management – One territory representative for streamlined and efficient service.
- 24/7 Technical Support with Help Desk so help is quick and easy when you need it most.
- Start to finish service with continuous support after system Go Live.
- IQ/OQ/PQ, Mappings, Validation, Calibration, Preventive Maintenance and Data Migration
Partner models consist of a healthcare institution operating a specialty pharmacy in partnership or in contract with another entity to offer the full range of services required for an accredited specialty pharmacy. Accreditation standards are a valuable resource to healthcare pharmacy leaders to ensure that all internal and partner specific regulatory components are in place.…Details
It is critical for any healthcare institution to understand the details of applicable laws and regulations to structure its approach to specialty pharmacy practices. The first step is to do a gap analysis of state and federal regulations pertaining to specialty pharmacy services. Risk Evaluation and Mitigation Strategies (REMS) requirements for specific products must also…Details
Specialty drugs are distinguished by two main characteristics: cost and complexity. Specialty drugs are expensive because of their delicate nature such as limited shelf life, need for climate-controlled shipping and meticulous storage. Specialty drugs are complex because they require special handling and services, inventory management and intense administration. They also need a high level of…Details
Mesa has created a service network specifically suited to provide in-house services to our customers. Whether your needs call for equipment repair, calibration or process validation, Mesa’s Global Services team is uniquely qualified to provide you with specialized service, expert protocol development and execution and complete validation services to suit every need.
The Mesa Labs Difference
When looking for a monitoring program, Mesa Labs understands that you are not simply looking for software to monitor your equipment, you are looking for a monitoring partner to help you protect valuable product and archive valuable data. Monitoring systems prove their worth when called into action and the systems from Mesa Labs provide you with extremely effective and efficient alarming systems able to communicate via phone, text and email when conditions drift outside of your defined acceptance ranges.
Paramount to any Continuous Monitoring System are its capabilities when an alarm situation occurs. Varying the alerting by department, piece of equipment, time of day, day of the week, condition parameters, delivery method and escalation protocols can mean the difference between immediate/appropriate action and interaction, and coworker frustration and product loss.
Mesa Labs offers a suite of professional services to maintain its monitoring systems in optimal operating condition. Our personalized services are tailored to guide you in the transition to a fully automated monitoring system following installation. On-going support services are designed to maintain streamlined operations.
-Initial System Installation & Setup
-Transition Period Support & Go-Live Services
-Consulting & Other Professional Services
Mesa Labs has developed a complete validation protocol to meet rigorous FDA and other regulatory requirements. Our comprehensive Installation, Operational, and Performance Qualification (IQ/OQ/PQ) protocol validates compliance with the FDA 21 CFR Part 11 and facilitates our customer’s ability to meet GxP guidelines and 21 CFR Parts 210/211 requirements. Test execution is documented in the protocol test pages using Good Documentation Practices. Upon completion of the protocol, the client receives a detailed summary report; the executed protocol and all raw data, and all supporting documentation in a single turnover binder. Any deviations encountered during testing are identified and resolved prior to final document delivery to the client.