We are using Jira to organize our Mendix software developement. Parts of the development software need to have a Computer system Validation. I do wonder how Jira can help to get the required type of documentation together.
Also what are the precondition to use Jira for these type of purpose.
Looking into https://www.linkedin.com/pulse/using-scrum-validate-software-during-agile-nick-veringmeier/ it should be possible to use Jira.
I am looking for a guidance to use Jira in a most efficient way
The article you shared discusses how the Scrum approach to projects can support the Computer System Validation methodology (which appears to be a highly specified waterfall approach to the deliverables between a Supplier and a Regulated Company).
Jira is a very flexible tool supporting Scrum, Kanban, and other Business processes.
You can certainly use Jira to support this approach. The details are well beyond what the Atlassian Community can provide here in these forums.
You'll likely want to consult with someone who has extensive Jira Administration experience. They can provide the kind of guidance you're looking for, and help to configure Jira to support that highly customized methodology.
This might be a good next step for you:
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