How do you handle a delay in the CAPA if it’s caused by your manager? How do you write the justification?
In Scilife, if you have a delay in the CAPA, you can change the due date of the action or the due date of the CAPA, with a justification, of course. You will be signing electronically on the justification, and this will be captured in the official audit trail.
Is there a way to view the KPI data based on departments or teams?
Yes, there is. You can use the filters found at the top of the KPIs module to filter by group. It depends on how you have structured the groups. You can define different departments, teams, or operations—whatever you need. You can also use tags; if you have created a specific tag, you can use it to see that data. There is a set of different filters that you can apply and combine.
Is the CAPA workflow that we have seen validated? Or does it have to be validated by the customer? Moreover, is this software itself validated?
The software is definitely validated. We validate it according to GAMP 5 and 21 CFR Part 11. We perform a full validation and document everything. Typically, we provide a complete validation documentation package to the customer, which they can leverage for their own validation plan. Customers will need to validate the system again based on their intended use. With the package we provide, about 90 to 95% of the initial validation effort is already completed. This includes the CAPA workflow.
You have shown how you can involve people in the investigation of the deviation and also in the CAPA plan. But if these two items are linked, how does this limit the options for assigning participation to the CAPA?
We assign the deviation to a group, such as "General," and then link it to a CAPA, which has two groups assigned: "General" and "GMP."
When creating the CAPA, you have the freedom to add more groups. You will have the group assigned to the deviation, but you can also include additional groups if needed. For example, if you need to involve a subject matter expert from a different department, you can add another group of people to participate in the CAPA. The CAPA is linked to the event, but this does not limit who can be assigned to participate in an action.
Could you briefly explain the use of the root cause analysis, template?
For root cause analysis, various methodologies and tools can be used, such as the 5 Whys, the fishbone diagram, and others. This template helps collect and organize data effectively. It includes four columns:
- Issue Details: Report the date of the deviation or event and provide a name or ID for it.
- Issue to Report: Describe the issue, including its source and location, and rate its criticality to your processes as medium, low, or high, based on your procedure.
- Root Cause: Define a possible root cause, though it doesn’t have to be final. Include the probability rating and any relevant details.
- Suggested Solutions: Describe potential solutions, list any risks associated with implementing them, and provide information on how to measure success using KPIs or metrics.
This structured approach helps in documenting and analyzing issues systematically, facilitating more effective problem-solving.
