A GAP audit or delta audit is a review conducted to determine whether a company meets the regulatory requirements in the medical device industry. It identifies potential gaps where the organisation is not in compliance with the required standards or regulations.
A GAP audit usually consists of the following steps:
- Preliminary meeting to clarify the objectives of the delta audit.
- Process analysis: Consideration of the actual state.
- Comparison of the analysis with the target state, identification of the gap(s)
- Proposing measures for change
- Implementing the measures, concluding the GAP audit in an audit report.
These audits enable those responsible to react to changes before they take effect. In addition, the necessary measures are identified and implemented in a targeted manner.