DHR approval requirements for stand-alone software

K

keldez

Involved In Discussions
#1
#1
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!
 
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Y

yodon

Leader
Super Moderator
#3
#3
Re: DHR approval requirements

Interesting topic of discussion.

Consider what a DHR is: essentially evidence that the DMR was followed. So what's the DMR for the stand-alone software? Probably isn't one but you probably have (or should have) build instructions and maybe some SCM/SQA stuff (like configuration status accounting and configuration identification) that you do.

From strictly a management / controls perspective, it's important to capture this information and other information about the configuration (known issues, issues resolved, etc.).

I'm curious if anyone is pushing you for a DHR for software? I'd hesitate to try to label anything for software as a DHR since that only begs the question about the DMR.
 
mihzago

mihzago

Trusted Information Resource
#4
#4
Re: DHR approval requirements

let me expand a little bit on my previous response, to show you what I'm doing.

The release notes document is actually a combination of several software QA items, which includes software revision description and changes made, build procedure, description of executable file, archive location, deployment information and any pertinent software configuration management information.

In my document/record control procedure I define DHR to be a record with this information.

My product is a stand-alone software, which is not delivered on any physical media; it's either available thorough web link or app store. You may need additional information related to production if you deliver your software on CDs or similar.
 
K

keldez

Involved In Discussions
#5
#5
Re: DHR approval requirements

We do have life-cycle documentation - There's a Revision History document (per 62304) of builds, dates, descriptions. We created a DMR Index (albeit limited in content). The only thing we are lacking that I'm aware of on that end is fulfilling process controls.
After more thought, I almost wonder if this running log/record in question is just a link between the existing Revision History document and referencing it to our Verification activities (what proves it has been accepted per DMR requirements). As what it seems you have Mihzago, I'm basically making a record of existing data from multiple sources.
No one is pushing us at the moment to meet any requirements. I'm building this QMS from the ground up with the classification of this software. My colleagues and I come from different worlds in terms of Quality, so I just want to ensure I'm not overdoing it.
I think I will keep our DHR log as a record as planned, and reference the Revision History Document and DHF to prove acceptance. Thanks all!
 
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