Who can complete this task?
  • Veeva Quality Basics users with QMS Creation Permission for Audits

This work instruction applies to audits created outside of an audit program.

To create an external or internal audit:

  1. Navigate to QMS > Audits & Supplier Management > External Audits or Internal Audits and click Create.

    screenshot step 1

  2. Fill out all required fields. Note the following.

    • Auditee: For external audits, this is the supplier being audited.

    • Audited Department: Only displays for internal audits. For internal audits, you need to provide either the Auditee or Audited Department.

    • Owning Organization: Can either be your organization (in house audits) or another supplier (outsourced audits).

    • Planned Start Date: When part of an audit program, audits will be created automatically 14 days prior to the planned start date.

  3. Click Save.

    screenshot steps 2 and 3 external audits

    screenshot steps 2 and 3 internal audits

Define Team

  1. Navigate to the Audit and click Manage Team.

    screenshot step 1

  2. Specify an Audit Owner, one or more QA Approver(s), and optionally, one or more Co-Auditor(s). Co-auditors are users who may also contribute to the audit report.

  3. Click Save.

    screenshot steps 2 and 3

Send for Preparation (In-House Audits Only)

When you’re ready, you can start the audit workflow. If the audit is being conducted in-house, it will be sent for preparation.

To send an audit for preparation:

  1. Navigate to the audit and select Send for Preparation from the Workflow menu.

    screenshot step 1

    The audit owner will receive a task to complete the audit preparation.