evan_kim90
Starting to get Involved
Hi,
I am new to this industry and am learning a lot from it.
Recently, I got a question regarding some of our processes.
1. Does each batch record have to be signed by quality personnel? Or is it okay to be signed by a supervisor or manager in production? If we have to sign by quality personnel, which standards are based on? (ISO13485, MDR, or FDA)
2. How can we decide on sampling for verification? The FDA or ISO now want us to decide the sample number based on risk. But how exactly can we set the sampling number during verification or other processes?
Thank you and I hope I can get great idea from this discussion.
I am new to this industry and am learning a lot from it.
Recently, I got a question regarding some of our processes.
1. Does each batch record have to be signed by quality personnel? Or is it okay to be signed by a supervisor or manager in production? If we have to sign by quality personnel, which standards are based on? (ISO13485, MDR, or FDA)
2. How can we decide on sampling for verification? The FDA or ISO now want us to decide the sample number based on risk. But how exactly can we set the sampling number during verification or other processes?
Thank you and I hope I can get great idea from this discussion.