Atul,
If you are using a tool like Azure Dev Ops, this is no different than using any other software tool in software development process and should be managed as such. It is probably too much to include in this post, but need to look at configuration management, tool qualification or validation, and supplier control. You are correct it may need to be validated or should be validated as part of quality system activities.
Managing a Design History File (DHF) for software products can be done a number of different ways. The important aspect is the information is traceable and retrievable such as during an audit or inspection. This can be done manually or electronically, using various tools which are available. There has been a couple other posts about managing DHF for software which has been provide in the past in this forum. Indeed, software DHFs can change frequently which can be challenging, but there are different ways which this can be done.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Oct-2023 22:44
From: Anonymous Member
Subject: Software as medical device change management (SaMD), azure dev ops
This message was posted by a user wishing to remain anonymous
If you're using agile methods to develop the software, you should probably be using agile methods to manage the documentation at the same time.
One caution about storing the DHF in a code repository... When the company is being inspected, it will be necessary to have the documentation readily available, in easily readable formats. Ease of access by the quality team and everyday convenience for the engineering team are both very important.
Original Message:
Sent: 23-Oct-2023 20:12
From: Atul Deo
Subject: Software as medical device change management (SaMD), azure dev ops
Hi,
I had 2 questions
1) Typically Azure Dev Ops or similar tool is being used for software development. Dev Ops itself can store documents- for eg requirement docs, FMA ect but can we use Dev Ops for that purpose and how to go about validating dev ops for that. Any risks for maintaining docs in azure dev ops?
2) Software devices may undergo frequent design changes and it is hard to keep up with design history file for software products, what tools are available to better manage the maintenance of DHF ? or it has to be a manual process of updating DHF document and releasing it in document control system, any thoughts or ideas around this please?
Thank you in advance for your help!
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Atul Deo
Project Lead
Auckland
New Zealand
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