Within various aspects of a quality management system, there is a directive to evaluate the root cause of an issue – this could be risk management, investigations, non-conforming material, corrective actions, etc. There is a specific process to this concept, along with methods to achieve the answers. A root cause is a factor, or combination…Details
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Background A medical device manufacturing facility in Carlsbad, CA has two ISO Class 8 cleanrooms, an ultra low temperature freezer with epoxies, and a home style fridge. One cleanroom is temperature only, and the other is temperature, humidity and differential pressure. For Quality Control, the cleanrooms and the areas outside of them are required to…Details
The next logical discussion is the second half of the Corrective and Preventive Action (CAPA) subject. According to ISO 9001 section 8.5.3, Preventive Actions identify and eliminate the causes of potential nonconformities in order to prevent occurrence. These are proactive measures, instead of the reactive steps taken for a Corrective Action. The main goal for…Details
The Virginia Cooperative Extension has released a publication discussing the validation of blue crab retort processes. The development and implementation of a Hazard Analysis Critical Control Point (HACCP) plan is a required step for these retort processes. In the publication, we learn about: What a retort cook process validation is Why this process matters How…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.