As computer usage became more mainstream, especially as a way to store records, the FDA received a request from various industries for guidance on the use of electronic signatures and submissions to the FDA. The FDA’s response to this request was to issue 21 CFR Part 11 in 1997, which covers electronic signatures, records and…Details
Wireless, Hardwired & Hybrid Monitoring Solutions
What We Monitor
- Temperature (TMP)
- Differential Pressure
- Open/close Alarm
- Air Velocity
- Power Line
- Door Switches
- Particle counters
Assets We Monitor
- Ultra Lows
- Liquid Nitrogen Units
- Stability Chambers
- Walk-in Refrigerators/Freezers
- Storage Areas
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
Looking for assistance? Contact our Technical Support Team or submit a Support Ticket today
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Anyone has the ability to review the FDA database of 483’s, warning letters and FDA statements. Upon reviewing that information, there are essentially eight areas where companies are facing challenges in regards to supplier oversight: Confusion between internal and external suppliers – There has always been confusion in determining whether a company’s other site(s) or…Details
It is recommended that your Continuous Monitoring (CM) system undergoes a “major tuneup” at least once annually. Although there are monthly or quarterly alarm checks and preventive maintenance schedules to complete, an annual probe calibration to an NIST or ISO 17025-traceable standard and a comprehensive system check/validation will ensure the system is in good working…Details
Over the past year, we have been keeping an eye on the progress of duodenoscope reprocessing. In early 2015, the practice was called into question after the deaths and infections of patients from being exposed to a multidrug-resistant “superbug” related to the reprocessing of these single-use medical devices. The Association for the Advancement of Medical…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 Monitoring Difference
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.
-Initial System Installation & Setup
-Transition Period Support & Go-Live Services
-Consulting & Other Professional Services
Mesa Monitoring 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.