Q
QAtemp
I am with a company that is a distributor that distributes a product that is specified as medical grade material. We do not manufacture the material. We receive the material in and pretty much ship it out. Sometimes we re-package the material into smaller packages when requested by a customer.
I am currently writing the Quality Manual and I am not sure how applicable Sections "7.5.1.1 Control of production and service provision" and "7.5.2.1 Validation of processes for production and service provision" are to our business. We do not perform any value added processes.
When we do re-package, we QC sample test some of the material. It involves some analytical equipment that utilizes software. So, another question is "Should that software be validated?"
Thanks!
I am currently writing the Quality Manual and I am not sure how applicable Sections "7.5.1.1 Control of production and service provision" and "7.5.2.1 Validation of processes for production and service provision" are to our business. We do not perform any value added processes.
When we do re-package, we QC sample test some of the material. It involves some analytical equipment that utilizes software. So, another question is "Should that software be validated?"
Thanks!