As part of a company’s quality management system, there must be consideration for the equipment used within the facility. According to the FDA’s 21 CFR 820, “Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained.” They also have the requirement that all inspection, measuring and test…Details
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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
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
Per customer request, with DataTrace Pro v1.3 you can now merge data from a stand-alone DataTrace Pro DB to a remote one. The new “Synchronize Data” feature is available among others, such as: Data Management Group Controls Reporting Food Specific Applications Lethality Oversight More information on these features can be found in our January 2016…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.