Audit Management

The Audit Management module supports the full audit lifecycle — from planning through finalization. Use it to conduct internal quality audits and supplier audits, record findings, and generate signed reports.

View the audit list

1. On the left sidebar, select Audits.
2. Review the Audit Plans table, which shows each audit’s number, title, type, status, priority, lead auditor, start date, and findings count.
3. To narrow results, use the Filters card above the table:
   • Enter text in the Search audits… field to search by title or audit number.
   • Select a value from the All Statuses dropdown to filter by status.
   • Select a value from the All Types dropdown to show only Internal or Supplier audits.
   • Select a value from the All Priorities dropdown to focus on a specific priority level.

Create an audit plan

1. On the left sidebar, select Audits.
2. Select New Audit Plan in the top-right corner.
3. Fill in the audit details: title, description, type, priority, scope, objectives, planned dates, and team assignments (lead auditor, auditors, auditees).
4. Select Save to create the audit plan.

View audit details

1. On the left sidebar, select Audits.
2. In the audit table, select the eye icon on the row you want to open.
3. Use the tabbed interface to navigate between sections:

Tab	Contents
Overview	Audit information, scope, objectives, executive summary, recommendations, key dates, and statistics.
Findings	List of audit findings with filtering and creation capabilities.
Comments	All comments across findings for the audit.
Reports	Generated audit reports with signing and download options.
Documents	Uploaded internal and external documents.
Timeline	Chronological record of audit events.

Edit an audit

1. On the left sidebar, select Audits.
2. In the audit table, select the pencil icon on the row you want to edit.

Note

The pencil icon appears only if you are the audit creator or an Admin.

Start a planned audit

1. On the left sidebar, select Audits.
2. In the audit table, locate the audit with Planned status.
3. Select the play icon on that row.

Note

Only the assigned lead auditor can start an audit.

Complete an in-progress audit

1. On the left sidebar, select Audits.
2. In the audit table, locate the audit with In Progress status.
3. Select the checkmark icon on that row.

Note

Only the assigned lead auditor can complete an audit.

Export audit data

1. On the left sidebar, select Audits.
2. Select Export in the top-right toolbar.
3. Choose the export format and confirm.

Audit types

Type	Description
Internal	Audits of your own quality management system processes and departments.
External	Audits conducted by or for external parties such as customers or partners.
Regulatory	Audits driven by regulatory bodies (e.g., FDA, Notified Body) or in preparation for regulatory inspections.
Supplier	Audits of external suppliers, with support for external document uploads and auditor access.

Audit lifecycle

1. Planned — The audit is scheduled with scope, objectives, dates, and team assignments.
2. In Progress — The audit is actively being conducted; findings can be recorded.
3. Completed — Fieldwork is finished, all findings are addressed, reports are generated, signed, and the audit is finalized. Completing an audit requires a signed final report.
4. Cancelled — The audit has been cancelled and will not proceed.

Caution

Completing (finalizing) an audit requires a signed final report and is irreversible. Ensure all findings have been addressed and reports are complete before finalizing.

Permissions

Action	Required Role
View audit list	Admin, QA Team, or audit.view permission
Create audit	Admin, QA Team, or audit.create permission
Start / Complete / Finalize audit	Admin, QA Team, or Lead Auditor
Edit audit	Audit creator or Admin
Upload documents	Admin, QA Team, Lead Auditor, or assigned auditees (supplier audits)

Tip

The audit detail page shows key statistics at a glance, including total findings and open findings count. Use this to quickly assess audit progress without navigating to the Findings tab.

Practical example: managing an internal audit end-to-end

Scenario: MedDevice Corp schedules an annual ISO 13485 internal audit of its Design Control process. Sarah Chen (QA Manager) is the lead auditor.

1. Plan the audit. Sarah navigates to Audits and selects New Audit Plan. She enters:

   • Title: “Annual Design Control Audit 2026”
   • Type: Internal
   • Scope: “Design control procedures (SOP-DC-001 through SOP-DC-009), design history files for products released in the last 12 months”
   • Objectives: “Verify compliance with ISO 13485:2016 clause 7.3 and 21 CFR 820.30”
   • Planned dates: 2026-03-16 to 2026-03-20
   • She assigns two auditors and three auditees from the R&D department.

2. Start the audit. On March 16, Sarah opens the audit detail page and selects Start Audit. The status changes to In Progress.

3. Monitor progress. During the week, Sarah checks the audit detail page regularly. The statistics panel shows “4 Total Findings / 2 Open” at a glance without needing to open the Findings tab.

4. Review findings. She selects the Findings tab and filters by severity Critical to prioritize the most serious issues first. She reviews evidence attachments and adds comments requesting additional information from the R&D team.

5. Generate the report. After fieldwork wraps up, Sarah selects the Reports tab, generates a PDF report titled “Design Control Audit Report — March 2026” with all content sections enabled, then signs it.

6. Finalize. With the signed report in place, Sarah finalizes the audit. The status moves to Completed and the audit is locked.

7. Export. She selects Export to download the audit data for inclusion in the upcoming management review meeting.

Related topics

• Creating Audits — Step-by-step guide to planning a new audit
• Audit Findings — Recording and managing findings
• Dispute Resolution — Handling finding disputes
• Audit Reports — Generating and signing reports
• External Auditor Access — Granting access to external auditors