A requirement of ISO 9001, ISO 13485 and the FDA’s 21 CFR 820 is in regards to complaint files. According to 21 CFR 820, a complaint is defined as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is…Details
Whatever you need, our Mesa Continuous Monitoring System has a solution. Easy to install and capable of integrating with your existing network infrastructure, our advanced software will enable you to remotely monitor your refrigerators, freezers and other vital assets throughout your facility in real-time.
Real-time monitoring of fleet conditions including geolocation, geofencing, refer unit run times and door status in addition to product conditions such as temperature and humidity. This solution is designed to keep you in compliance while transporting your sensitive goods.
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
The information you need, all in one place. Documents, Certificates, Spec Sheets, Videos, helpful Links and FAQs
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Once product has been manufactured and packaged, there are requirements for how you handle, store and distribute the finished product. 21 CFR 820 breaks down the requirements for each of these processes. A manufacturing company should establish procedures that will deter mix-ups, damage, deterioration or contamination from happening during handling and storage of product. These…Details
Usually one of the last items you think of when designing a new product, the packaging actually provides a critical function. It is the barrier between the world and your medical device – meant to keep your product intact and functioning as designed. Medical device packaging must be tested for stability. This will provide assurance…Details
Manufacturers are required to have labels for product and product labeling. According to the FDA in section 201, a label is a “display of written, printed, or graphic matter upon the immediate container of any article” whereas “labeling includes equipment labels, control labels, package labels, directions for use, maintenance manuals, etc.” 21 CFR 820 specifically…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.