Prior to the on-site audit activities, evaluate the auditee’s records to determine the compliance of the system, as documented, with audit criteria.

The documentation may include:

• Relevant management system documents and records
• Applicable standards
• Site master file
• Registration files
• Guidelines
• SOP’s
• Protocol or Project specific requirements
• Previous audit reports
• Adverse drug reactions
• Records of the company in relation to complaints and recalls

Documentation Review

When reviewing the auditee’s documentation, create a checklist or aide mémoire of the points, to be confirmed during inspection.

If the documentation is found to be insufficient, notify the auditee and decide whether the audit should be continued or suspended until documentation concerns are resolved.