GAP Analysis
Written procedures describe operational expectations. A GAP Analysis ensures that all components of that system; 1) are present, 2) minimize regulatory risk, 3) represent best business practice, 4) are fit for purpose.
Insite QA takes a step wise, scalable approach to performing a GAP Analysis. We have developed a proprietary GAP Analysis tool that is built on regulatory requirements and best business practices. The first step in our process of assessing process completeness is to apply our GAP Analysis tool. This tool affords us the ability to quickly analyze your procedures to identify high level procedural gaps.
The second step in our process utilizes RACI diagrams, such as the one below, to ensure that all procedural elements are included in your procedures.
Process mapping follows RACI assessment. This ensures that written processes are logical, do not contain GAPs or redundancies and that they include the correct inputs and hand-offs.
After procedural implementation, a performance evaluation for ongoing systematic improvements can be customized for your needs.