I have a question for the hive mind. For those of you who have implemented Jira in the FDA regulated, 21 CFR Part 11, validated world, did you complete a risk assessment of the functionality/intended use/etc as part of your validation effort? If yes, what sort of risks did you capture?
Thanks for your help,
Yes you need to carry our a risk assessment on Jira and your specific use of Jira.
Assuming that we are talking only about electronic records, typically the risks related to Jira are:
1) Jira bugs or misbehavior:
a. Loss of data
b. Corruption of data
c. Modification of data
2) User action:
a. Loss of data
b. Modification of data
c. Security issues
Others may be applicable depending on the exact use you make of it.
This leads you to the consideration of common controls such as backup management, access management, credentials and permissions, training and integrity checks.
If you need more info just let us know.
Hello Chris (and everybody else),
We have recently launched a service to provide a fully 21 CFR 11 compliant turnkey solution based on Atlassian tools. Check this if you are interested.
We can also help you set it up yourself in your own instance if you prefer.
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