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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The information you need, all in one place. Documents, Certificates, Spec Sheets, Videos, helpful Links and FAQs
Mesa Labs recently hosted a Webinar on Process Validation within the Quality System. We are now happy to provide the recording of the entire 45-minute informational presentation, led by our DataTrace Product Manager, Bradley Pickard, to answer the following questions: Do I have confidence in my manufacturing process, or what scientific evidence assures me that my process…Details
The MPRF Data Logger armor is specifically tailored to protect the MPRF Temperature Data Logger. Made of Tecaform material plastic, it is thick and form-fitted to protect the logger against more industrialized environments. It is the perfect solution for a rugged environment where the logger may get dropped or thrown, or subjected to liquids. This…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
3 Reasons to Use DataTrace Pro
The software offers a “set it and forget it” type of calibration with industry standard controls and the ability to assess to a certain specified tolerance. It can calibrate loggers directly in the software and communicate with industry standard or leading metrology equipment. This saves time and energy while giving you the control over the calibration to determine which data points are being checked and verified. Your loggers will be kept within tolerance while removing hassle from the equation. Please note, it is still recommended that you receive factory calibration once per year, but performing it in house simplifies the process.
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.
Location is everything!
If your sensors are in the wrong place, you can’t get accurate readings. We offer a wide range of accessories to ensure the proper placement of your loggers so you get the most reliable data. And, we can create custom accessories for even the most unique processes.