The Audit Management module from Grand Avenue Software assists customers in scheduling, planning, executing, implementing, reviewing and reporting their audit activities.

The activities start with the Audit Administrator initiating audits in the system by denoting the scope of each audit, the lead auditor, the planned start date, and the type of audit (internal, external, supplier). Lead auditors establish the requirements for their particular audits. Checklists available from Grand Avenue for ISO 13485:2003 and the Medical Device Directive (MDD) may be used to populate the requirements of an audit. Customer-specific requirements may also be imported into the system. Any combination of checklists and site specific requirements could be used to establish the specific requirement for each particular audit. Figure 1 shows an example of a lead auditor defining the requirements for an audit:

Figure 1: Checklist of Audit Requirements.
Example requirements from section 8 Measurement, Analysis and
Improvement of the ISO 13485:2003 checklist.

Audit results are recorded for each requirement in the audit. Requirements are marked as conforming, nonconforming, or not applicable. Each result may be detailed with one or more findings. Findings that may be recorded include observations, major nonconformances, and/or minor nonconformances. Findings may result in Corrective and Preventive Actions (CAPA) and/or may be documents with audit actions already completed. Figure 2 shows an example of an audit with results recorded for its requirements:

Figure 2: Recorded Results for Audit Requirements.
Audit results, findings, CAPAs and actions have
been recorded for requirements in the audit.