Software validation - off the shelf X-Ray



Hi Everyone,
we have an off-the-shelf X-Ray equipment, used to measure molded components.
the software has a model built for each component, and when the component is measured - the equipment compares the measured values to the model, to determine whether the measured components meet specs.
the equipment is validated and calibrated, but I wanted to check if a software validation is required for this kind of equipment (for medical devices)



Super Moderator
If the software is involved in the processes you mention (comparing, making decisions, etc.) then yes. That would fall under 21 CFR 820.70:

(i) Automated processes. When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.

Ajit Basrur

Yes Don is spot on. You could also check with the equipment manufacturer if they have validated the software and that could help you in determining what level of software verification may be required for the intended use.
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