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Worksheet: Audit Readiness

Ensure your site is ready for an FDA audit

Having plans in place to outline procedures, documentation and key roles and responsibilities is vital when preparing for an FDA audit.

One way your site can prepare is to develop an audit-readiness checklist. This provides a guide for staff to use to ensure your processes are followed.

The audit readiness checklist includes:

  • Collecting info for your inspection
  • Notifying key staff
  • Preparing your site for an audit
  • Gathering and delivering documents

Download the checklist to use a framework for audit readiness at your site. Be sure to take the unique elements and roles/responsibilities at your site into account to ensure an efficient, effective process.

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