A
aklug
We are doing a validation for a medical device customer we need to send the protocol out for inspection... I am not comfortable with this as I believe the validation inspection should be done on our own equipment to keep with the nature and intent of the validation process. However, I am not the only person making this decision.
Can someone please tell me if subcontracting the validation inspection to a third party is acceptable? (point: I was not told if this was discussed with the customer prior, our approved protocol did not list our equipment specifically and the subcontractor will be using the type of equipment specified in the protocol)
Thank you for all your help.
Can someone please tell me if subcontracting the validation inspection to a third party is acceptable? (point: I was not told if this was discussed with the customer prior, our approved protocol did not list our equipment specifically and the subcontractor will be using the type of equipment specified in the protocol)
Thank you for all your help.
