Preparing for FDA inspection? If you’d like to try Jira for this purpose, you’re in the right place. Some medical companies use Jira to comply with CFR 21 Part 11 regulations. When built-in features can help (Jira audit log, for example), combining it with plugins available on Atlassian Marketplace, you can meet the essential requirements. Everything depends on your interpretation of the FDA regulations. In this article, we’ll overview what tools you can check for Part 11 compliance.
Part 11 establishes specific rules that manufacturers must follow to maintain the integrity of their systems. 21 CFR Part 11 is not just about ensuring the integrity of your records, however, it is also about protecting your QMS and keeping your corporate secrets under lock and key from unauthorized users.
Part 11 was developed to meet the emerging needs of the medical device industry to help companies:
All requirements can be broken down into the following general categories: access management, data integrity&security, audit trail, and electronic signatures.
Built-in Jira features can help to get an audit log for some system changes and get an issue changelog on a single issue level. Usually, to comply with Part 11, you need more advanced tools.
Now, let’s consider what tools you can use to fulfil every requirement.
An audit trail or audit log records all changes that users make to some file or database. That’s the main reason why FDA is checking you: to ensure your data is authentic and prevent falsifications or discrepancies. Complete issues changelog: this is why Issue History for Jira was created.
What will you get with the Issue History for Jira?
Another part of the audit log is system changes. Jira’s built-in audit log captures the history of system changes like logins or adding new users. You can use it for security purposes.
Auditor for Jira was invented to track all admin activities. It addresses the issue of incomplete data regarding prior actions taken by numerous Jira administrators.
You can filter activities to display by event type, date range, user or IP address. Events are sorted in chronological order.
With the help of the app, you may verify user credentials in accordance with the technical requirements of 21 CFR Part 11, which lays out the conditions under which digital records and digital signatures are similar to paper records and are trustworthy, dependable, and valid.
Depending on your company specifics, there are lots of things to consider if you want to try Jira for 21 CFR Part 11 compliance.
Built-in features that can help:
Plugins to check:
You can choose one or combine the apps like Issue History + Electonic Signatures. Find what works best for you.