Creating Audits

This page covers how to create an audit plan, fill in required details, assign auditors and auditees, and transition the audit from Planned to In Progress.

Prerequisites

To create an audit, you need one of the following:

Role / Permission	Access
Admin or QA Team role	Full create access
audit.create or audit.manage permission	Create access

Create a new audit plan

1. On the left sidebar, select Audits.
2. In the top-right corner, select New Audit Plan.
3. Complete the required fields described below.
4. Select Create Audit Plan.

The system redirects you to the audit detail page. The audit receives an auto-generated audit number and is set to Planned status.

Required fields

Field	Description
Title	A descriptive name for the audit (for example, “Annual Quality System Audit 2026”).
Description	The purpose, background, and context for this audit.
Audit Type	Select Internal for internal QMS audits, External for external party audits, Regulatory for regulatory-driven audits, or Supplier for supplier audits.
Scope	Define what areas, processes, or departments will be audited.
Objectives	List the specific goals of the audit.
Planned Start Date	When the audit fieldwork is expected to begin.
Planned End Date	When the audit fieldwork is expected to finish.

Optional fields

Field	Description
Auditees	People or departments being audited.
Auditors	Team members conducting the audit.
Audit Criteria	Standards, regulations, or internal requirements the audit measures against (for example, ISO 13485, 21 CFR 820).
External Auditors	Email addresses of external auditors who are not system users. They receive access via verification code.
External Auditees	Email addresses of external auditees who are not system users.

Assign auditors and auditees

1. In the Auditees or Auditors field, start typing a name or email.
2. Select the person from the dropdown list.
3. The selected person appears as a badge below the field.
4. To remove someone, select the X on their badge.

Tip

You can assign multiple auditees and auditors to a single audit. This is useful for cross-departmental or multi-site audits.

Start an audit

After the audit plan is created and the team is ready:

1. On the left sidebar, select Audits.
2. Select the view (eye) icon on the audit row to open the audit detail page.
3. Select Start Audit.
4. In the confirmation dialog, select Confirm.

The audit status changes to In Progress and the actual start date is recorded.

Note

Only users with Admin, QA Team, or Lead Auditor roles can start an audit. The Start Audit button appears only when the audit is in Planned status.

Edit an existing audit

1. On the left sidebar, select Audits.
2. Select the edit (pencil) icon on the audit row.
3. Modify the fields as needed.
4. Select Save.

Edit access is limited to the audit creator and Admin users.

Practical example: creating an ISO 13485 internal audit

Scenario: PharmaTech Ltd needs to audit its Document Control process against ISO 13485:2016 clause 4.2.4 before an upcoming Notified Body visit.

1. Navigate to Audits and select New Audit Plan.

2. Fill in the required fields:

   Field	Value
   Title	Pre-Certification Document Control Audit Q1 2026
   Description	Internal audit of the document control process to verify compliance with ISO 13485:2016 clause 4.2.4 and SOP-QMS-003 prior to the scheduled Notified Body surveillance audit in May 2026.
   Audit Type	Internal
   Scope	Document control procedures, document approval workflows, obsolete document handling, and electronic document management system (EDMS) configuration across the Quality and Regulatory Affairs departments.
   Objectives	1) Verify that all controlled documents follow the approved review and approval workflow. 2) Confirm obsolete documents are identified and prevented from unintended use. 3) Assess EDMS access controls and version management.
   Planned Start Date	2026-03-23
   Planned End Date	2026-03-25

3. Fill in optional fields:

   • Auditors: Add Maria Lopez (QA Specialist) and James Park (QA Associate).
   • Auditees: Add Karen Wells (Document Control Manager) and Tom Reid (Regulatory Affairs Director).
   • Audit Criteria: ISO 13485:2016 clause 4.2.4, 21 CFR 820.40, SOP-QMS-003 Rev 5.

4. Select Create Audit Plan. The system creates audit number AUD-2026-004 and opens the detail page in Planned status.

5. On March 23, open the audit detail page and select Start Audit. Confirm in the dialog. The audit transitions to In Progress and the actual start date is recorded.

Next steps

• Record audit findings
• Generate audit reports