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The aim of validation is to ensure that the components of a system work together to produce the intended result for which the system was designed.Whereas verification focuses on the right operation of a process (or product) itself, validation tends to focus on the right output of the process.The key point is to develop methods for easy validation and revalidation. Krause published a guide for analytical method transfer, comparability, maintenance and acceptance criteria for the testing of biopharmaceuticals (18).This primer gives a review and a strategy for the validation of analytical methods for both methods developed in-house as well as standard methods, and a recommendation on the documentation that should be produced during, and on completion of, method validation.We apply this same concept to our line of Portable Calibration Units (PCU), which combine three battery-powered flow meters of complimentary ranges in a single case, all with High-accuracy Calibration.This instrument is the big brother of a single portable meter, able to calibrate flow devices across a very broad array of flow ranges.Ask three people what these terms mean, and you will get three different answers.
Furthermore, their interpretation and application vary from industry to industry.For volumetric measurements, the low pressure drop of our Whisper Series provides an unobtrusive way to measure volumetric flow rates with minimal affect on the flow rate being measured.A validation process ensures that the components of a system function together to meet the need or intent of a customer or regulating body.Alicat mass flow meters and pressure gauges purchased with the “HC” (High-accuracy Calibration) option can serve as NIST-traceable secondary calibration standards in the field.
An Alicat portable that is calibrated as a transfer standard becomes a portable rapid calibration lab.It also describes what is important when transferring a method.