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 permission	Create access

Create a new audit plan

1. On the left sidebar, select Audit.
2. In the top-right corner, select Plan audit. The audit creation page opens.
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
Auditors	The people conducting the audit. Colleagues with an account, plus any external invitees.
Auditees	The people and functions being audited. Colleagues with an account, plus any external invitees.
Audit Criteria	Standards, regulations, or internal requirements the audit measures against (for example, ISO 13485, 21 CFR 820).

Assign auditors and auditees

Each of Auditors and Auditees has two separate controls: one for colleagues who already have an account, and one for inviting somebody who does not.

Add a colleague

1. In the Auditors or Auditees field, start typing a name or email address.
2. Select the person from the list. Use the arrow keys and Enter, or the mouse — the list is fully reachable from the keyboard.
3. The selected person appears as a badge below the field.
4. To remove someone, select the X on their badge.

Invite someone external

Directly beneath each people picker is an Invite someone external field, for people without an account.

1. In Invite someone external, enter the person’s email address.
2. Select Invite, or press Enter.
3. The address appears as a badge marked (external), listed separately from your colleagues.
4. To withdraw an invitation, select the X on its badge.

External invitees receive access to the audit through a verification code sent to that address. See External auditor access.

Note

Inviting by email is its own labelled field. Previously, both kinds of participant shared one input and the system guessed which you meant based on whether what you typed looked like an email address. Splitting them means you always know which list a person is going into, and an address that is not valid is rejected as you type rather than when you save.

Tip

You can assign multiple auditees and auditors — internal, external, or both — 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 Audit.
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 the audit’s assigned lead auditor, or a user with the audit.admin permission (Admin by default), can start an audit. The Start Audit button appears only when the audit is in Planned status.

Cancel an audit

If an audit is called off before it is completed — for example the scope is withdrawn or it is superseded — you can cancel it. Cancellation is only available while the audit is in Planned or In Progress status; a completed or finalized audit is an immutable record and cannot be cancelled.

1. Open the audit detail page.
2. Select Cancel Audit.
3. Enter a cancellation reason (required — it is written to the audit trail).
4. Complete the electronic signature: select Get verification code, enter the 6-digit code emailed to you, then select Cancel audit.

The audit status changes to Cancelled. This is a terminal state — a cancelled audit cannot be restarted.

Note

Cancelling an audit is a 21 CFR Part 11 electronic signature. Only the audit’s lead auditor (or a user with audit-admin permission) can cancel it, and the Cancel Audit button appears only for Planned or In Progress audits.

Edit an existing audit

1. On the left sidebar, select Audit.
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’s creator, its lead auditor, and users with the audit.update or audit.admin permission (Admin and QA Team hold audit.update by default).

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