Hi,
we are currently reviewing the Computerized System Validation requirements for a planned collaboration with another company, who, among others, produce parts for use in aviation applications (as a supplier for an aircraft manufacturer). While we are familiar with CSV in medical devices, we are not sure how to interpret the requirements from the AS9001, in particular 8.5.1.1 Control of Equipment, Tools, and Software Programs: Equipment, tools, and software programs used to automate, control, monitor, or measure production processes shall be validated prior to final release.
Does this mean we need to validate all software assets that might have an influence on quality of the final parts? How does this work in practice in aviation, do we need to have a similar approach here as we have in CSV for medical devices, and does this get audited? Or do are we viewing this topic based on our medical device requirements, and in aviation this does not need to be controlled as closely, especially for suppliers not directly involved in the manufacturing of aircrafts?
I did find very little concrete information regarding this topic online, I would greatly appreciate any input or guidance you might have to steer me in the right direction. Our partner so far uses very little technology in their production environment and have a different approach to quality control from us, therefore they also cannot give us much information.
Thanks!
Marcus
we are currently reviewing the Computerized System Validation requirements for a planned collaboration with another company, who, among others, produce parts for use in aviation applications (as a supplier for an aircraft manufacturer). While we are familiar with CSV in medical devices, we are not sure how to interpret the requirements from the AS9001, in particular 8.5.1.1 Control of Equipment, Tools, and Software Programs: Equipment, tools, and software programs used to automate, control, monitor, or measure production processes shall be validated prior to final release.
Does this mean we need to validate all software assets that might have an influence on quality of the final parts? How does this work in practice in aviation, do we need to have a similar approach here as we have in CSV for medical devices, and does this get audited? Or do are we viewing this topic based on our medical device requirements, and in aviation this does not need to be controlled as closely, especially for suppliers not directly involved in the manufacturing of aircrafts?
I did find very little concrete information regarding this topic online, I would greatly appreciate any input or guidance you might have to steer me in the right direction. Our partner so far uses very little technology in their production environment and have a different approach to quality control from us, therefore they also cannot give us much information.
Thanks!
Marcus
