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What is the Recommended Approach for Control on Non-Regulated Laboratory Instrumentation?

Michael Ambrose, Vice President of Lab Services and Solutions at USDM Life Sciences says his approach would be for a calibration or a qualification. For instance, if it's a basic instrument, he’d still want to calibrate it. He would still want to have a set of requirements to say what the calibrations test points and ranges should be and make sure that that system is producing data that I could consider valid, even if it's not going into a regulatory document or submission. The same with qualification. He would definitely have manufacturer's specifications being met before I installed an instrument and the analogy I use often is a librarian is going to want to get their books back if they're using a software to track it. They're going to want to do some type of testing, make sure the software works, make sure it's installed properly and that would go for any of the basic laboratory equipment. The place he would maybe change if it wasn't validated, if it wasn't regulated, would be a validated system.

Ambrose says he might not do the extent of extra documentation, but would certainly have requirements and testing around any software that was used in a lab just for data integrity and data security reasons.

USDM Life Sciences offers a complete suite of laboratory enterprise validation and compliance services led by a core team of highly qualified, scientifically trained laboratory instrument/systems specialists.


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