Audit Preparation - Are You Ready?
11/08/09 11:11 Filed in: Audit/Inspection
Readiness
Regulatory Audit Preparation – Are You Ready?
Philip
Russ, Innovative Consultants GXP
Would you know what to do if the
FDA showed up at your door? Even more importantly,
would the company receptionist know what to do? The
best thing QA and Compliance professionals can do is
to provide tools to prepare your organization for a
regulatory inspection, and facilitate this
preparation through practicing these skills in a safe
and mentoring environment. A place to start is to
prepare tools for:
- Understanding the purpose of the inspection and your regulatory filing
- Conducting a Quality Systems Gap Assessment for inspection preparation
- Inspection logistics and site preparations
- Preparing computer and automated systems for regulatory review
- Special considerations for laboratories and process equipment
- Utilizing inspection results for competitive advantage
- Interview techniques including how to conduct a site tour and how to give a software demonstration
So you think your ready? A good way to find out is by answering these questions honestly and with objective evidence to support your answer.
Do your people know how to conduct a regulatory audit?
Is your senior management ready?
Is your staging room ready?
Is your audit room ready?
Is your receptionist ready?
Are your Subject Matter Experts Ready?
Is your development report/DHF ready?
Is your facility ready?
Is your tour guide ready?
Is your product or software demo ready?
Is your lab ready?
Are your documents ready?
Are your suppliers ready?
Is the CAPA system ready?
Are your decisions ready?
Does FDA think your ready?
Does your internal audit program make you ready?
How do you stay ready?
We have all heard the adage “Fail to plan, plan to fail”, and in no area is this more relevant than inspection readiness. Your competitors are actively monitoring the outcomes of regulatory inspections and will try to use this information to their competitive advantage. Creating a system to assist in planning for audit and regulatory inspections accurately and executing them effectively should be a priority objective for QA and Compliance organizations in any regulated industry.