While Jira is already a great platform for issue tracking and business process management, we find that boosting it with plugins makes it much more useful for quality management purposes. Here we list some of our favourites and explain the value they add.
Note: At the time of writing, all these plugins are only available for Jira Server instances.
Electronic Signature (InTENSO Labs)
This plugin addresses the electronic signature requirement of FDA CFR 21 Part 11. I love it because it removes the need to create signature records separately from the process and saves on paperwork.
It’s also very easy to configure. Simply define an ‘InTENSO Electronic Signature’ custom field for each signature you need to collect in a process. For example, if the customer support team needs to sign off a customer issue before closing it, just add an electronic signature field to the relevant form.
An electronic signature is required to close a customer issue
A couple of points to bear in mind:
- This plugin fulfils only the electronic signature requirement of FDA CFR 21 Part 11 compliance. The audit trail, which is the second major requirement, is built into Jira by default.
- The plugin has a few options that can be configured by system administrators. Some of them are crucial for compliance, for example the one that means the sign-off can only be performed by the user logged in at the time. Beware that the default settings are not always compliant with the legislation and you will also need to make sure the settings you select comply with your organisation’s own policies.
Elements Connect
The Elements Connect plugin can be used in many contexts, but we usually use it to achieve one particular effect – to link two issues in a way that’s more specific than Jira’s built-in ‘issue links’ mechanism allows.
For example:
- Jira maintains your list of training topics, eg sterilisation process training and customer issues training, as well as your actual training tasks (ie training particular people on specific training topics). The Elements Connect plugin allows you to populate fields in a training task using information from the equivalent fields in the relevant training topic.
- When a corrective and preventive action (CAPA) is created as a result of a nonconformity, Elements Connect allows you to indicate the specific nonconformity record in the ‘source’ field of your CAPA.
Elements Connect comes with good documentation and support. However, to configure it you will need at least a basic understanding of SQL and HTML.
Using Elements Connect to populate dropdown list for source field in CAPAs.
Dynamic Forms (InTENSO)
This plugin allows you to define the appearance and behaviour of one field in a screen based on those of other specified fields. We use it to promote best practice in the way processes are managed.
Often a quality management process will have to accumulate different information depending on the data users put in. For example, when handling a CAPA, it’s good to have a checklist of questions that encourage (or force) users to consider particular things. If a user answers ‘yes’ to a certain question, Dynamic Forms will enable another relevant question to appear, like this:
- Could this CAPA affect risk management?
- Can you provide a short explanation of how?
- Is the CAPA related to a process or a product?
- Which process or product?
- Has a similar CAPA been raised in the past?
- Which CAPA was it?
Dynamic Forms allows us to ask all these questions without overloading the Jira forms. Only the first level questions will appear on the screen and the additional fields will only appear, dynamically, as appropriate.
This means the forms look simple, despite being geared up to collect a high degree of detail. That makes for a much better user experience without compromising on the quality and depth of information collected.
JJUPIN (Kepler Rominfo)
Last, but definitely not least, the JJUPIN plugin extends the workflow processing capabilities of Jira almost indefinitely. It makes it possible to tie sophisticated business logic and automation into the processing of issues.
I’m yet to encounter a quality management process flow that can’t be implemented with a few short JJUPIN scripts.
Here are some examples of where JJUPIN scripting can come in handy:
- If a nonconformity has triggered the creation of a CAPA, we can prohibit the closure of the nonconformity until the CAPA has been validated.
- If a CAPA has been validated, and an effectiveness check is not required, we can skip this default behaviour and close the CAPA.
- An engineering change request (ECR) will have many subtasks associated with it, such as design activities and completing documentation. We can enable the ECR to move automatically to a new status once all associated subtasks have been performed.
There are other powerful automation and scripting plugins in the Jira marketplace. However JJUPIN requires the shortest learning curve and the most limited understanding of Jira’s internal structure. All the scripting can be done directly from Jira’s user interface, using a basic information model to represent the complex Java programming that’s actually at work behind the scenes.
Anyone who has ever programmed in C can quickly master scripting with JJUPIN to implement automation in Jira.
Plugins like these enable us to tailor Jira to meet the needs of a wide variety of life sciences companies. If you’d like to find out more about how we could help you transform your quality assurance workflows with Jira, please get in touch.
