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

If it is a basic instrument, it is best to have it calibrated. It is important to have a set of requirements to say what calibration set test points and ranges are producing data that are considered valid, even if it's not going into a regulatory document or submission.

The same process is recommended with regards to qualification. It is best to have met manufacturer specifications before instrument installation. You should do some type of testing, make sure the software works and that it is installed properly; that would go for any basic laboratory equipment.

Lab Systems that are not validated nor regulated would not need extra documentation, but it is still a best practice to have requirements and testing around any software that was used in a lab for data security and data integrity 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.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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