T
thejbster
Hi Folks,
I have a question regarding how companies have interpreted the FDA regs (and ISO) relating to Complaints. We are trying to determine whether any software bug that might be found internally should fall into the Complaints process as if it had been reported by a customer? For example, when testing as part of development of a new release we may sometimes uncover an obscure bug which exists in a previously distributed product, but which has never been found or reported by a customer.
Should this be classified as a Complaint? If not, under what process would you capture and review it?
Thanks
thejbster
I have a question regarding how companies have interpreted the FDA regs (and ISO) relating to Complaints. We are trying to determine whether any software bug that might be found internally should fall into the Complaints process as if it had been reported by a customer? For example, when testing as part of development of a new release we may sometimes uncover an obscure bug which exists in a previously distributed product, but which has never been found or reported by a customer.
Should this be classified as a Complaint? If not, under what process would you capture and review it?
Thanks
thejbster