Hi,
We develop software under medical devices. Our software team is using a well established version control software for among other things capturing code changes. 13485 7.5.6 Validation of processes for production and service provision has "The organization shall document procedures for the validation of the application of computer software used in production and service provision."
I am interpreting this to mean the off the shelf software we use for version control is required to be validated. Is my interpretation correct?
Thanks
Quinn
We develop software under medical devices. Our software team is using a well established version control software for among other things capturing code changes. 13485 7.5.6 Validation of processes for production and service provision has "The organization shall document procedures for the validation of the application of computer software used in production and service provision."
I am interpreting this to mean the off the shelf software we use for version control is required to be validated. Is my interpretation correct?
Thanks
Quinn