If you need to maintain information for an FDA inspection or submission, Jira is a great tool to use. Be aware, however, that the Code of Federal Regulations Title 21, part 11 requires you to be able to export that data from the system into a readable, precise document:
11.10. (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records.
When setting up Jira to support regulated process, you must ensure the export includes all elements of the Jira issue, including:
- Regular and custom fields in a human-friendly layout
- The history of the issue
- Information about all electronic signatures provided for the ticket
- Any necessary supportive attachments
- Sub-task information with all the bits of information (history, electronic signatures, etc.)
- The export date, time, and name of the person who exported it
- Company-specific styling, including logo, disclaimers, etc.
My go-to tool when setting up an FDA-compatible export is Midori Global Consulting’s PDF View plugin for Jira. This powerful plugin allows you to export any FDA-required issue into a world-class, well-designed, professional document. There are plenty of informative examples included with the tool, which takes you a long way towards implementing the export you need. All custom field types or rich text situations are covered, and any necessary attachment is integrated in its original format as an embedded file. You also can invoke dynamic scripts in the export process, giving you access not only to sophisticated calculations but also to Jira’s entire third-party API universe. For example, I use InLabs’ Electronic Signature to easily add customisable electronic signatures. The resulting PDF is a self-contained and complete package of information that, using the tool’s own API, can easily be exported as part of the issue workflow or in any automation cycle.
The only downside of this plugin is you need technical know-how to implement it. The export requires basic notions of three technologies: .FO Syntax, Velocity templates, and Jira’s own API, so be advised you will need access to development skills to implement it.
Because your business relies on creating accurate, complete records, it’s imperative you use the best tools possible to generate your exports. There’s an art to delivering the right information that satisfies regulations.