Free on the site is the Vendor Audit Check List, a very handy document, not the same as the Vendor Audit in our shop, which has an analysis tool which allows you to prioritize and personalize the audit scoring, to enable accurate and justified comparisons to be presented to your client or manager.
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The follow on to the vendor audit check list, whether it pertains to in-house or out-house audits is the Gap Analysis Tool. This quantifies the scope of work involved in attaining regulatory compliant status. As a consultant, the most often asked for service as soon as you arrived in a clients office is, a gap analysis. It is what everyone wants, a searching look into at all aspects of your current systems, to determine compliance and adequacy of current procedures. A gap analysis involves comparing regulatory requirements against current procedures and facilities in your facility. Differences are referred to as "gaps." It gives tremendous reassurance that the ship is water tight and under command.
The Gap Analysis tool allows you to systematically challenge the company’s cGMP policies and procedures, comparing them with the regulatory expected standards and allowing you to draw up a list all delinquencies. Until you can highlight the company’s deficiencies, you are not able to scope the task of becoming compliant. This is where the Vendor Audit Check List makes It possible for you to know what resources are required for the task.