Hello All,
I am creating a DHR system for stand-alone software. I'm caught in between methodology - current management has never shown approval on DHRs with previous companies. It has more or less contained the version/date/customer. This is because every software build has to undergo verification, and once it is verified, those design control records show approval to the DMR. So, all "units" of a version are built and approved in one step.
I see the logic in management's stance, but the DHR is still a record, so I feel it needs to have document controls applied.
For some background, our proposed DHR structure is an electronic log that is part of our ERP (Confluence), and for each sale a row is added to the DHR "log" to apply as much unique identification as possible (UDI not required yet) by Customer ID. Once a line is added, the log goes through the approval process (electronic via our Workflow).
Any thoughts on the need for approval of this application of the DHR?
Thanks!
I am creating a DHR system for stand-alone software. I'm caught in between methodology - current management has never shown approval on DHRs with previous companies. It has more or less contained the version/date/customer. This is because every software build has to undergo verification, and once it is verified, those design control records show approval to the DMR. So, all "units" of a version are built and approved in one step.
I see the logic in management's stance, but the DHR is still a record, so I feel it needs to have document controls applied.
For some background, our proposed DHR structure is an electronic log that is part of our ERP (Confluence), and for each sale a row is added to the DHR "log" to apply as much unique identification as possible (UDI not required yet) by Customer ID. Once a line is added, the log goes through the approval process (electronic via our Workflow).
Any thoughts on the need for approval of this application of the DHR?
Thanks!