M
Is there a 13485, FDA or other requirement to re-validate equipment annually even if it has not been changed, modified, moved etc.?
We have an internal document that states as follows.
Re-val is required when Equipment is modified relocated or otherwise changed in a manner which may impact the process. In no changes are made to equipment they are re-validated annually.
This statement was added during a previous revision. I know the first sentence is required, but I am not sure about the annual requirement. I would like to revise it to say it will be reviewed annually to determine if Re-val is needed OR remove the 2nd sentence all together.
Equipment that requires calibration is required at least annually, but I'm not sure that was the intent of the 2nd sentence.
Thank you
We have an internal document that states as follows.
Re-val is required when Equipment is modified relocated or otherwise changed in a manner which may impact the process. In no changes are made to equipment they are re-validated annually.
This statement was added during a previous revision. I know the first sentence is required, but I am not sure about the annual requirement. I would like to revise it to say it will be reviewed annually to determine if Re-val is needed OR remove the 2nd sentence all together.
Equipment that requires calibration is required at least annually, but I'm not sure that was the intent of the 2nd sentence.
Thank you

