CAPA Categories are used to manage the assignment, escalation, and expected resolution time for Corrective Actions. Each Category has a default rule, and sub-rules can be created to allow assignment, escalation etc. based on Facility/Location. 


To add a CAPA Category, start by logging into the web app and selecting the Actions tile:

  1. Click the drop-down menu.
  2. Click Categories.
  3. Click New.





Next, enter the Category settings:


  1. Enter a Category Name.
  2. Select the Owner of this CAPA. The Owner can reassign the CAPA if needed, and add Notes on how to resolve the CAPA. This list will only contain Users.
  3. Select the person this CAPA would be assigned to. The Assigned To can only view CAPA notes, change the status/resolve the CAPA, and upload attachments. This list will contain Users and CAPA Recipients.
  4. Optional: Select users to be notified, or copied, on Corrective Action assignment emails.
  5. Enter the Days To Resolve. (the default number of days a person has to resolve Corrective Actions in this category).





Next, Complete the Escalation tab:

  1. Click Escalation.
  2. Select a First Escalation To. If this CAPA is still unresolved, it remains assigned to the original person, but the First Escalation user is notified. (Please note: Multiple First Escalation users can be selected.)
  3. Select a Second Escalation To. If this CAPA is still unresolved, it remains assigned to the original person, but the Second Escalation user is notified. (Please note: Multiple Second Escalation users can be selected.)
  4. Enter the First Escalation Days (the number of days from the Due Date to perform the First Escalation. e.g. -1 would be 1 day before due date).
  5. Enter the Second Escalation Days (the number of days from the Due Date to perform the Second Escalation. e.g. 0 would be on the due date).
  6. Click Update.






If there should be different CAPA settings for each Facility, or for a different Inspection Category, create the overall category, then click on it. Now, you can create a Custom Assignment Rule.







Now, enter the details:

  1. Select the Owner of this CAPA. The Owner can reassign the CAPA if needed, and add Notes on how to resolve the CAPA. This list will only contain Users.
  2. Select the person this CAPA would be assigned to. The Assigned To can only view CAPA notes, change the status/resolve the CAPA, and upload attachments. This list will contain Users and CAPA Recipients.
  3. Optional: Select users to be notified, or copied, on Corrective Action assignment emails.






Next, Complete the Escalation tab:

  1. Select a First Escalation To. If this CAPA is still unresolved, it remains assigned to the original person, but the First Escalation user is notified. (Please note: Multiple First Escalation users can be selected.)
  2. Select a Second Escalation To. If this CAPA is still unresolved, it remains assigned to the original person, but the Second Escalation user is notified. (Please note: Multiple Second Escalation users can be selected.)
  3. Enter the First Escalation Days (the number of days from the Due Date to perform the First Escalation. e.g. -1 would be 1 day before due date).
  4. Enter the Second Escalation Days (the number of days from the Due Date to perform the Second Escalation. e.g. 0 would be on the due date).





Next, complete the Filters tab:

  1. Optional: Select the Facility this custom assignment rule applies to. You can filter further by Level 1, Level 2, and Location if these rules should be very specific.
  2. Optional: Select the Inspection Category this custom assignment rule applies to. 
  3. Click Update.






To edit a CAPA Category, highlight its name, and click edit. 

To remove a CAPA Category, highlight its name, and click Delete. Please note: A CAPA Category cannot be removed if it is in use.