Software Validation

Has the Image J software been validated?
Can and should it be validated prior to use? Typical software installation expectation requires IQ, OQ, PQ and am looking for justification for use without it.

Welcome to the forum, @theQ!

Please see these threads on the old ImageJ mailing list where this has been discussed in the past:

http://imagej.1557.x6.nabble.com/Validation-tp3697192.html

http://imagej.1557.x6.nabble.com/validation-for-Helsinki-committee-tp5015279.html

http://imagej.1557.x6.nabble.com/IMAGEJ-ISO-certification-state-tp4532455.html

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You may also have a look at the article

M. Kaufmann et al. (2010)
“Guide for using Open Source** Software (OSS) in Regulated Industries based on GAMP”

that can be downloade from here.

Here is another comment regarding the topic.

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