Volume 1 of this three-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component , and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these are referenced to the relevant relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors, and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A CD-ROM packaged with the book contains all of the checklists in a customizable electronic format.
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