Hi ,
Any advice or guidance from any one on ERP system software validation.
ERP software was purchased of the shelf.
Very low risk associated with it as its used to record stock but we also have a paper based system so it more of a back up.
Need to validate as per ISO13485 2016
4.1.6
"The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.
The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software."
Might anyone have a template or sample validation or a validation protocol for the like?
Have been googling but found nothing of any use.
Thanks in advance
Any advice or guidance from any one on ERP system software validation.
ERP software was purchased of the shelf.
Very low risk associated with it as its used to record stock but we also have a paper based system so it more of a back up.
Need to validate as per ISO13485 2016
4.1.6
"The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.
The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software."
Might anyone have a template or sample validation or a validation protocol for the like?
Have been googling but found nothing of any use.
Thanks in advance