Deviation Management

Deviation Management provides a centralized system for documenting, tracking, and resolving any departure from approved procedures, specifications, or standards. The module enforces SLA-based deadlines, supports AI-powered classification, and integrates directly with CAPA to drive corrective and preventive actions.

Report a new deviation

1. On the left sidebar, select Deviations.
2. Select Report New Deviation.
3. Fill in the deviation form: title, description, severity, linked SOP, and detection date.
4. Submit the form.

Report a deviation from a template

1. On the left sidebar, select Deviations.
2. In the filter bar, select Use Template.
3. Choose a pre-built or custom form template.
4. Complete the pre-populated form and submit.

Filter deviations by status

1. On the left sidebar, select Deviations.
2. In the filter bar, open the All Statuses dropdown.
3. Select a status: Open, Under Review, Pending Approval, Approved, or Rejected.

The table updates to show only deviations matching the selected status.

Filter deviations by date range

1. On the left sidebar, select Deviations.
2. In the filter bar, enter a start date in the Date From field.
3. Enter an end date in the Date To field.

The table updates to show only deviations within the specified range.

View the SLA status summary

1. On the left sidebar, select Deviations.
2. At the top of the page, review the Deviation SLA Status card.

The card shows counts across five categories: Overdue, Approaching, On Track, No Deadline, and Total Active.

View overdue deviations only

1. On the left sidebar, select Deviations.
2. Select View Overdue Deviations.

The table switches to show only deviations that have passed their due date. Select View All Deviations to return to the full list.

Tip

The overdue view is helpful during daily stand-ups and management reviews to quickly identify deviations needing immediate attention.

View a deviation’s details

1. On the left sidebar, select Deviations.
2. Find the deviation in the table and select View in the Actions column.

The detail page is organized into three tabs:

• Details & Actions — Displays deviation metadata including title, description, severity, status, reported-by user, linked document/SOP, detection date, and reporting date. If a CAPA is linked, its ID and status are shown.
• Timeline — Shows the full audit trail with creation, status changes, approvals, rejections, and linked CAPA events displayed chronologically.
• Comments — A collaborative thread for discussion, investigation findings, and resolution coordination.

Update a deviation’s status

1. On the deviation detail page, select Update Status.
2. In the modal, select the new status: Open, Under Review, Pending Approval, Approved, or Rejected.
3. Optionally enter a resolution description.
4. Select Update.

Caution

When approving a deviation, the system may require you to verify your identity by clicking Get Verification Code and entering the 6-digit code sent to your email. This is a regulatory compliance requirement under 21 CFR Part 11.

Create a CAPA from a deviation

1. On the deviation detail page, select Create CAPA.
2. The system creates a new CAPA record linked to the deviation.
3. On the left sidebar, select CAPA to define corrective and preventive actions on the new record.

Note

The Create CAPA button is only visible when no CAPA is already linked and you have the capa.create permission.

Export deviation data

1. On the left sidebar, select Deviations.
2. In the filter bar, select Export.
3. Choose the export format and optional status filter.

Severity levels

Level	Description
Low	Minor deviation with negligible impact on product quality or patient safety.
Medium	Moderate deviation requiring investigation but no immediate product risk.
High	Significant deviation with potential impact on product quality.
Critical	Severe deviation requiring immediate attention and escalation.

Permissions

Permission	Description
deviations.read	View deviations and the deviation list.
deviations.approve	Update deviation status, approve, or reject deviations.
capa.create	Create a new CAPA from a deviation.

Note

The overdue deviation view is restricted to users who have both the deviations.read permission and an Admin or QA role.

Practical example: managing a pH excursion deviation

This walkthrough shows a deviation moving through its full lifecycle in a pharmaceutical manufacturing context.

Scenario: During in-process testing of Batch #2026-0312, a QC analyst detects that the buffer solution pH is 7.8, outside the validated range of 7.2-7.4.

1. Report the deviation

1. On the left sidebar, select Deviations.
2. Select Report New Deviation.
3. Enter the following:
   • Title: pH excursion in buffer preparation — Batch #2026-0312
   • Description: During in-process pH testing of phosphate buffer solution for Batch #2026-0312, the measured pH was 7.8, exceeding the validated range of 7.2-7.4. The batch was placed on hold immediately. Affected equipment: Buffer vessel BV-04. The excursion was detected during routine IPC at 10:15 AM.
   • Severity Level: High (the AI suggestion may also recommend High based on the out-of-spec result)
   • Related SOP/Document: SOP-BUF-003 Buffer Preparation Procedure
   • Date Detected: 2026-03-07
4. Select Report Deviation.

2. Investigate and update status

1. On the deviation detail page, select Update Status.
2. Change the status to Under Review.
3. Use the Root Cause Analysis panel to run a 5 Whys analysis.
4. Add a comment: “Preliminary investigation indicates NaOH titrant was from a newly opened lot (Lot #T-4421). Requesting COA from vendor.”

3. Create a CAPA

1. After confirming the root cause, select Create CAPA on the deviation detail page.
2. Define corrective actions (for example, retest the NaOH titrant lot, retrain operators on titrant verification).
3. Define preventive actions (for example, add incoming titrant verification step to SOP-BUF-003).

4. Approve and close

1. Once the CAPA actions are completed and the effectiveness review is approved, return to the deviation detail page.
2. Select Update Status and change to Pending Approval.
3. A QA manager reviews the full record and changes the status to Approved, providing an electronic signature.

The deviation now has a complete audit trail from detection through resolution, linked to its CAPA record.