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Which pieces of equipment require equipment validation?

racglobal

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#1
Hi everyone,

Working in a a small startup, my questions concern equipment validation.

1- How can we know which pieces of equipment need equipment validation? I come from a regulatory background; if anyone has some strong quality background, I'd like to hear your insights.
2- For each piece of equipment that needs validation, is it necessary to go through IQ, OQ, PQ?

Thank you.
 
#2
No, not every piece of equipment requires validation. To quote ISO13485.

"The organization shall validate any processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered."

I would suggest going through each piece of equipment or process and assessing whether the output can be verified. This essentially means 100% verification. Remember the test itself is a process and should also be validated.

Nothing says you must use the labels IQ/OQ/PQ. It is also common, when appropriate, to combine IQ and OQ together. However, these are the most commonly used steps.
 
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