We are a SaMD and are utilizing GitHub for hosting software development code and providing code management such as branches, tags, and version control. All our validation and verification will be done through GitHub, but will ultimately be uploaded in our eQMS for review and approval.
For our ASL we have the following:
Class 1: Critical-direct commercial product impact.
Types of Services: Contract manufacturers / developers, critical components, finished product, product labeling, etc.
Class 2: Non-critical direct commercial impact.
Types of Services: Non-critical components that do not have a risk to safety or defectiveness, etc,
Class 3: Indirect and/or no commercial product impact.
Types of Services: Validated software, QMS Consulting, pest control, graphic designer, etc.
FYI: I realize these are more along the lines of manufactures with parts and not software. We are a start-up and are just now beginning to review and update our recently released QMS now that we have the resources to do so.
My question is - what Class would you put GitHub under?
For our ASL we have the following:
Class 1: Critical-direct commercial product impact.
Types of Services: Contract manufacturers / developers, critical components, finished product, product labeling, etc.
Class 2: Non-critical direct commercial impact.
Types of Services: Non-critical components that do not have a risk to safety or defectiveness, etc,
Class 3: Indirect and/or no commercial product impact.
Types of Services: Validated software, QMS Consulting, pest control, graphic designer, etc.
FYI: I realize these are more along the lines of manufactures with parts and not software. We are a start-up and are just now beginning to review and update our recently released QMS now that we have the resources to do so.
My question is - what Class would you put GitHub under?