The FDA requires manufacturers to maintain Device History Records (DHR). Within ISO 13485, there isn’t a specific requirement for a DHR, but it does require the manufacturer to create all of the individual records the FDA requires the DHR to contain. The Device History Record is meant to be a collection of records containing all…Details
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Vital to the overall success of the project, a complete set of annotated floor plans for monitored appliances and points is important to have for the design, implementation and validation stages of system implementation. Here are examples of how and when floor plans are utilized: System Design – During the design phase of the project,…Details
Section 820.75 of the FDA Code of Federal Regulations Title 21 defines the Process Validation requirements of 21CFR820.70 – Production and Process Controls. The Process Validation requirements include: Validation of the production process is required if the final results of a process cannot be verified by subsequent inspection or testing. The validation testing and results,…Details
The U.S. Food and Drug Administration (FDA) has made two final Food Safety Modernization Act (FSMA) rules public: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals JDSupra Business Advisor published an article discussing an overview 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 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
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