Before you start

  • The CAPA is in Awaiting Effectiveness Verification.
  • You are named in QAs on the CAPA.
  • You know your Complere password.

Steps

  1. Open the CAPA from CAPAs and read its Effectiveness tab.

  2. Select the status button at the top of the page. The Escalate panel offers Escalate status to Closed and Escalate status back to Awaiting Effectiveness Review.

    Step 2. The Escalate panel of a CAPA in Awaiting Effectiveness Verification with Escalate status to Closed and Escalate status back to Awaiting Effectiveness Review

  3. Select the arrow beside Escalate status to Closed. The form asks for your password and an optional Remark. Select Sign.

Result

The CAPA is Closed.

What gets recorded

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

What the audit trail records

  1. You signed the CAPA closed.

    Action Type
    Change Status
    Username
    Your username
    Date Created
    Date and time of the action
    Activity
    "The CAPA has been signed by the QAs and its status has been updated from Awaiting Effectiveness Verification to Closed", followed by your remark.