CAPA Action Management

The CAPA record’s Actions tab is where you track and complete all corrective and preventive actions for that CAPA. This page covers how to move actions through their named transitions, provide evidence of completion, use bulk assignment, and file the effectiveness review.

Open a CAPA’s actions

1. On the left sidebar, select CAPA.
2. Open a CAPA record.
3. Select the Actions tab in the record’s navigation.

The Actions tab lists every corrective and preventive action for the CAPA, each with its own status controls.

Review the CAPA’s current stage

The Now panel at the top of the record shows where the CAPA stands and what happens next. While actions are being worked, it shows how many actions are complete (for example, “2 of 4 actions complete”), the action list with its controls, and — when an effectiveness review previously found the CAPA not effective — the review’s recommendations for follow-up. Root cause analysis, linked records (such as the source deviation), and the CAPA’s status badge appear in the record’s other sections.

Update an action status

Action state changes are named transitions, not a status dropdown. Each action card offers the transition that applies to its current state:

• Start work — moves a Pending action to In Progress.
• Complete & sign — completes an action (see below).
• Return to pending — reverts a completed action, for example when completion evidence turns out to be insufficient.

Start work and Return to pending open a confirmation dialog before anything is recorded; Complete & sign opens the signing dialog described below.

Complete an action

Completing an action always requires evidence of completion and an electronic signature:

1. On the action card, select Complete & sign.
2. In the signing dialog, describe the evidence of completion — what was done and how it can be verified.
3. Request a verification code (a 6-digit code sent to your email) and enter it to sign.
4. Confirm. The action shows as Completed with its evidence and completion date on the card.

Caution

Evidence of completion is required when completing an action, and every completion is electronically signed (21 CFR Part 11). The evidence and the signature are recorded in the audit trail.

Only the person the action is assigned to, or an administrator, can complete it. If you are neither, the Complete & sign control is replaced by an explanation of who can — it is not hidden.

Use bulk assignment

Bulk assignment lets you reassign multiple actions to a single user at once, from the CAPA’s own Actions tab.

1. Open the CAPA record and select the Actions tab.
2. Select Bulk assign (shown once the CAPA has at least one action).
3. In the Bulk CAPA Action Assignment dialog, search for and select the assignee.
4. Check the boxes next to the actions you want to reassign. Each action shows its current assignee and status.
5. Select Assign Actions.

Tip

Bulk assignment is useful when a team member leaves or when redistributing workload. You can select any combination of the CAPA’s actions.

Note

Bulk assign requires the same authority as editing the CAPA (capa.update) and is unavailable once the CAPA is closed. Someone without that permission — a User or Auditor, which never carry capa.update — still sees the button, but it is disabled with an explanation rather than hidden.

Review progress

While actions are in progress, the Now panel shows how many are complete (for example, “2 of 4 actions complete”). Each action card carries its own status badge, so the list itself is the progress view.

File the effectiveness review

Once every action is complete (and no review has been filed yet), the Now panel becomes the effectiveness review form — there is no separate effectiveness page:

1. In the Now panel, choose the review outcome: whether the CAPA was effective or not effective.
2. Record your findings and the evidence supporting the outcome. If the outcome is not effective, recommendations for follow-up are also required.
3. Select the primary action:
   • Sign & close CAPA (effective outcome) — requires an electronic signature via a 6-digit verification code sent to your email. Closing the CAPA locks its actions and attachments.
   • Record review (not effective outcome) — returns the CAPA to follow-up so the recommended additional actions can be added and worked.

Note

The effectiveness review only becomes available once every action has been completed; the system enforces this automatically. Filing it requires QA or administrator authority — controls you cannot use are shown disabled with the reason, not hidden.

Action fields

Each action card displays:

Field	Description
Description	What needs to be done.
Status Badge	Current status (Pending, In Progress, Completed).
Assignee	The user assigned to complete this action (“Unassigned” if none).
Due Date	Deadline for completion, when one is set.
Completed Date	Shown once the action has been completed.
Evidence	The evidence of completion recorded when the action was signed off.

Practical example: tracking actions for a cross-contamination CAPA

Scenario: A CAPA was created after a cross-contamination deviation where Product A residue was detected on equipment used for Product B. The CAPA has four actions.

Updating action statuses

1. On the left sidebar, select CAPA and open the cross-contamination CAPA.
2. The Now panel shows “0 of 4 actions complete”.
3. On the first action (“Perform additional cleaning validation swabs on shared equipment line EQ-14”), select Start work. Its badge changes to In Progress.

Completing an action with evidence

1. The cleaning validation is done and swab results are within acceptance criteria. On that action, select Complete & sign.
2. In the signing dialog, enter the evidence of completion: “Cleaning validation swabs performed on 2026-03-12. All 12 sampling locations on EQ-14 showed residue levels below 10 ppm acceptance criterion. Swab results documented in CV-RPT-2026-0034. Most challenging location (valve manifold): 3.2 ppm.”
3. Request the 6-digit verification code sent to your email, enter it, and confirm the electronic signature. The card now shows Completed with the evidence and completion date.

Using bulk assignment

The QA specialist originally assigned to three of the actions is on leave. Reassign to a colleague:

1. From the CAPA’s Actions section, select Bulk assign.
2. Search for and select “qa.specialist2@company.com”.
3. Check the boxes for the three actions.
4. Select Assign Actions.

Filing the effectiveness review

1. After all four actions show Completed (“4 of 4 actions complete”), the Now panel becomes the effectiveness review form.
2. Choose the outcome, record findings and evidence, and select Sign & close CAPA (effective) or Record review (not effective) to finish the CAPA’s final phase.

Permissions

Permission	Description
capa.update	Update action statuses, provide completion evidence, and bulk-assign actions.
capa.review	File or amend the effectiveness review once all actions are complete.

Production role grants: Admin and QA_Team hold capa.update; User and Auditor do not, and are shown the actions and their status but cannot update or bulk-assign them.