Audit Reports

The audit reporting system compiles findings, comments, dispute resolutions, and other audit data into a downloadable document. This page covers how to generate, download, and sign reports.

Generate a report

1. On the left sidebar, select Audits.
2. Select the view (eye) icon on an audit row to open the audit detail page.
3. Select the Reports tab.
4. Select Generate Report.
5. Enter a Report Title (for example, “Annual Audit Report 2026”).
6. Optionally, enter an Executive Summary with high-level findings and recommendations.
7. Select a File Format: PDF, HTML, or Word (DOCX).
8. Configure which content sections to include:

Option	Default	Description
Include Findings	On	All audit findings with severity, status, and descriptions.
Include Comment Threads	On	Discussion threads from findings.
Include Dispute Resolutions	On	Dispute submissions and resolution decisions.
Include Attachments	On	References to uploaded evidence and documents.
Include Audit Timeline	On	Chronological record of audit events.

9. Select Generate Report.

Tip

For regulatory submissions, include all content sections to provide a complete audit record. For internal management reviews, you may choose to exclude comment threads and attachments to create a more concise summary.

Download a report

1. On the Reports tab, locate the report card.
2. Select Download Report.
3. The report downloads in the format selected during generation.

Sign a report

Digital signing formalizes the report and indicates official approval.

1. On the report card, select Sign Report.
2. In the confirmation dialog, review the warning: “Are you sure you want to sign this report? This action cannot be undone.”
3. Select Sign to confirm.

After signing:

• The report displays a green Signed badge.
• The signer name and signing timestamp are recorded.
• A confirmation message appears: “This report has been digitally signed.”

Caution

Signing a report is irreversible. Once signed, the report is locked and the signer’s name and timestamp are permanently recorded. Verify the report contents before signing.

Generate additional reports

After a report is generated, select Generate Another to create an additional report for the same audit. This is useful for:

• Creating updated reports as findings are resolved.
• Generating reports in different formats.
• Producing separate reports for different audiences.

Report findings summary

Each report card displays a findings summary with counts:

Metric	Description
Total Findings	Total number of findings in the report.
Critical	Count of critical severity findings.
Major	Count of major severity findings.
Minor	Count of minor severity findings.

Report states

State	Description
Draft	Report generated but not yet signed.
Final	Report has been signed and is locked.

Permissions

Action	Required Role
View reports	Any user with audit access
Generate reports	Admin, QA Team, or Lead Auditor
Download reports	Any user with audit access
Sign reports	Admin, QA Team, or Lead Auditor

Practical example: generating and signing an audit report

Scenario: The “Pre-Certification Document Control Audit Q1 2026” (AUD-2026-004) is complete. Lead auditor Sarah Chen needs to generate the final report for management review and regulatory readiness.

Step 1: Generate the report

1. Sarah opens audit AUD-2026-004 and selects the Reports tab.
2. She selects Generate Report and fills in:
   • Report Title: “Document Control Audit Report — Q1 2026 (Pre-Certification)”
   • Executive Summary: “The Document Control process was audited against ISO 13485:2016 clause 4.2.4 and SOP-QMS-003 Rev 5. The audit identified 1 major and 2 minor findings. The major finding relates to obsolete documents remaining accessible on shared network drives without identification. Two minor findings address inconsistent revision history formatting and a missing signature on one document change request. Overall, the document control process is functional but requires targeted corrective actions before the May 2026 Notified Body surveillance audit.”
   • File Format: PDF
   • Content sections: All options enabled (Findings, Comment Threads, Dispute Resolutions, Attachments, Audit Timeline).
3. She selects Generate Report. The report card appears on the Reports tab showing: Total Findings: 3, Critical: 0, Major: 1, Minor: 2.

Step 2: Review and sign

1. Sarah downloads the report by selecting Download Report and reviews it for completeness and accuracy.
2. After confirming the content is correct, she selects Sign Report.
3. In the confirmation dialog she selects Sign. The report now displays a green Signed badge with her name and the signing timestamp. The report is locked and cannot be modified.

Step 3: Generate a management summary

1. Sarah selects Generate Another to create a second report for the management review meeting.
2. She enters the title “Document Control Audit — Management Summary” and selects PDF format.
3. She disables Include Comment Threads and Include Attachments to produce a concise summary.
4. She selects Generate Report. This second report remains in Draft state for now, as it does not require formal signing.

With the signed final report in place, Sarah can now finalize the audit from the audit detail page.

Related topics

• Audit findings
• Dispute resolution