HAWAI'I REGULATORY SERVICES
|Posted by hrs.jmorgan on January 12, 2012 at 5:45 PM|
What is a GAP Analysis?
A GAP Analysisis a tool that helps a company determine the steps to be taken in moving from acurrent state to a desired future-state. This helps provide the company withinsight into areas which could be improved. At its core are two questions:"Where are we?" and "Where do we want to be?"
What does it consist of?
A GAPAnalysis consists of two phases. PhaseOne involves determining, documenting and approving the variance betweenregulatory requirements and current capabilities. This is done by on-site andoff-site evaluation and communication with the client in an organized,systematic audit.
Phase Two involves preparing and implementing plansto fill the gaps. This involvesdevelopment of systems compliant with the Quality System Regulation (21 CFR 820in the US) and/or ISO 13485 and MEDDEV (EU). These systems lead to documentedprocedures and instructions the company uses as a roadmap for marketing medicaldevices in the US and EU.
Why is it Useful?
The GAPanalysis provides a foundation for measuring investment of time, money andhuman resources required to achieve a particular outcome. It is designed to bea proactive approach to management of the design, verification, manufacture, qualitycontrol, quality assurance, distribution and customer interaction for themedical device.