There are two different options in Scilife for defining your CAPA workflow:
- The first one offers the possibility of creating a more simple CAPA workflow in which the CAPA plan is described and carried out by one Responsible Person.
- The second option allows you to create a more complex CAPA in which various Users are implicated, giving you the possibility to set up as many Actions as you need and assigning each Action to different Users in the system.
This article describes the first option: Creating a CAPA with a simple workflow.
Creating a simple workflow CAPA
- Go to CAPAs > CAPAs.
- Click on the + icon.
In the CAPA Form:
You will see the page is divided into two parts, on your left-hand side you can include all the necessary relevant CAPA details for a simple workflow CAPA.
On the right-hand side, you will see the possibility of creating Actions, this is described in the article on complex CAPAs including various Actions and Users.
CAPA Mandatory fields
There are very few mandatory fields in a CAPA:
- Groups: Remember that only the people that are in the Group(s) to which you assign the CAPA will be able to see it.
- CAPA Title.
- Due date: Set a due date that is as realistic as possible.
- Responsible Person: from the drop-down list you can select the user who will be responsible for the CAPA.
- Select Approver(s): You can define more than one Approver. Depending on Module Settings, if you define several Approvers, they will all have to sign off on the CAPA.
- Select QA: You can define more than one QA. Depending on Module Settings, if you define several QAs they will all have to sign off on the CAPA.
CAPA optional fields
The number of optional fields you see will depend on the modules that have been activated in your environment. In other words, there are a series of standard optional fields that all users will see, and then there are also a few optional fields that will only be shown if the corresponding modules are active for you in your environment.
Standard optional fields
- CAPAs: you can link the new CAPA to other related CAPAs that are already in place in the system. This will only be possible if the option of Linking CAPA to CAPA has been enabled in Module Settings.
- Product/Service/Project: these have been preconfigured in Manage > Products/Services/Projects. When clicking on the Product/Service/Project field in the CAPA Form, the available options will appear and you can select as many as you need.
- Client/Vendor/Contact: these have been preconfigured in Manage > Clients/Vendors/Contacts but you can also add them on the fly when creating the CAPA in case you need to.
- Impacted Batch/Version/Aspect.
- Define CAPA Plan: In the case of a simple workflow CAPA, this field is particularly important seeing that this is where you can describe in detail the Actions that need to be performed. In more complex CAPAs, where you add the Actions one by one, the description does not need to be as detailed because all the Actions are described separately.
- Select Tags: by clicking on the field all available tags will appear, you can select more than one. If needed you can also create Tags on the fly by clicking on the Add New Tag button.
Module related optional fields
These fields will only be visible if the corresponding modules are active for you in your environment.
- Events: the CAPA you are creating may be a result of one or more Events that have taken place and that you have registered in the system. When creating the CAPA you will be able to link the CAPA to the Event(s) while these are Under Investigation.
- Audits: the CAPA you are creating may be a result of one or more Audits that have registered in the system. When creating the CAPA you will be able to link the CAPA to these Audits.
- Findings: the CAPA you are creating may be a result of one or more Audits Findings that have been registered in the system. When creating the CAPA you will be able to link the CAPA to these Audit Findings.
- Turn the User Selection Criteria switch ON if you wish to add Users that do not belong to the Group(s) to which you have assigned the CAPA in the roles of Responsible User, Approver(s), and/or QA(s).
- Regular Users will only be able to add Tags on the fly if Allow Regular User to create tags switch is turned ON in Manage > Permission Settings > General > Tags.