Create a CAPA

Before you start

• Administrator, Supervisor and Regular User can create CAPAs; Read Only User cannot.
• You know who will act as Coordinators, Approvers and QAs.
• Fields marked with a red asterisk (*) are required.

Steps

1. Open CAPAs from the menu and choose how much to fill in now.

   Full

   Select Full. The form opens at Basic Details, the first of its steps: Basic Details, Roles Configuration, Actions, Linked Items, Review and Submit. Follow the steps below.

   Minimal

   Select Minimal. A short form asks only for Groups, Category and Title, with Cancel and Submit.

   

2. Under System fields, select Groups. A Groups dialog opens: tick the groups the CAPA belongs to and select Ok.

3. Choose the Category. The Tentative ID appears, for example "Tentative ID : CAPA-8".

   Category	Use it for
   Corrective & Preventive	Both correcting a problem and preventing it from happening again.
   Corrective	Correcting a problem that happened.
   Preventive	Preventing a problem that has not happened.

4. Type the Title (no other CAPA may have the same title) and set the Due Date: select 1 Month, 2 Months, 3 Months or 6 Months, or pick a date from the calendar. Add Labels, Products, Contacts, Departments and Notifications if you need them.

   

5. Select Next. In Roles Configuration, choose the Coordinators, Approvers and QAs. You are named as an Initiator when you save.

6. Select Next. The Actions step ("Add Corrective & Preventive Actions for …") opens with Action 1 and its Tentative ID (for example CAPA-8-AXN-1). Fill in each action, then select Add Action for the next one. The counter beside Add Multiple shows how many more you can add.

   

   Field	What to enter
   Category	Corrective or Preventive.
   Actions	The kind of action: User-defined, Make New Document Version Effective or Get Users Trained In Training. For Make New Document Version Effective you choose the Documents; for Get Users Trained In Training, the Users and the Training. Those two kinds have no Details, Coordinators, QAs or Evidence required during closure.
   Title	What the action is (the field reads "Maximum 255 characters"). Each action in the CAPA needs its own title.
   Details	What has to be done (up to 500 characters).
   Coordinators and QAs	The people who carry out and sign off this action. Only the CAPA's own QAs are offered as the action's QAs.
   Evidence required during closure	The screen reads: "When enabled, actions can not be closed without uploading evidences".
   Closure Dependencies	Other actions of this CAPA that must be Closed before this one can be Closed. The action's Due Date then starts no earlier than theirs.
   Due Date	When the action is due, between today and the CAPA's due date (the screen shows the range).
   Supporting Files	Files to attach.

7. Select Next. In Linked Items, you can link the records the CAPA belongs to: choose the Module (for example Events), the Relationship (for an event, for example "is caused by (do not email Role Users once CAPA is closed)"), the Items and a Remark. Select Next.

8. On Review and Submit, check what you entered, then select Save. To finish it later, select Save As Draft instead: the CAPA is listed without an ID, and Edit on its row opens it again (CAPA › Update); finish it there with Update.

Result

• Complere confirms "CAPA created successfully" and opens the CAPA in Initiated, with its ID. It appears in the CAPAs list. Under the title, a counter shows how many of its actions are closed (for example "0 / 2, 0%, Action Closed").
• The CAPA's Roles tab lists the people you named. Next: an Initiator or a Coordinator signs to send it on; see How a CAPA moves from Initiated to Closed.

What gets recorded

Each entry appears on the CAPA's Audit Trail tab.

If something is different