Although each situation is unique and requires some form of intervention by knowledgeable personnel, this guideline was written to provide a “tool” for your investigation team. Following these basic instructions, the staff or individual responsible for a CAPA program will be able to fulfill most, if not all, of the requirements of a compliance auditor.
Our staff has made every effort to generate an outline of what is necessary to include in a CAPA program. An evaluation should be made to verify that all local or corporate standards are met concerning the program and the outline provided in this guideline.
This 26-page guideline was written to provide an outline of what is required to become compliant with a CAPA program.
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