Features:

• Standardizes audits and minimize subjectivity amongst auditors

• Provides easy, objective, and quantifiable results for management track and trend compliance

• Assures comprehensive auditing of all facets of applicable regulations and standards

• Enables auditors to easily trace checklist questions to the requirements in preparation for closing meetings

The world's most widely recognized QA manual has been updated to provide the audit system you need to assess compliance with these new standards/regulations and those that continue in effect.

Volume 1 of this 2 Volume Set 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.

Contents

Volume 1 includes checklists for: Internal Device Manufacturer/Developer, Internal Drug Manufacturer/Developer, Contract Device Manufacturer/Developer, Contract Drug Manufacturer/Developer, Contract Software Developer, General Supplier, Chemical Supplier, Printed Material Supplier, Electronic Component Supplier, Simulated QSIT Audit (FDA Approach), and New Product Market Launch - all referenced to the relevant FDA regs, EC and IPEC guidelines, and ISO/BSI standards. It also includes complete explanation of audit types, their advantages/disadvantages, do's and don'ts for auditors and guidance for audit preparation, performance, conclusion, report derivation and follow up activities.

The Software Package consists of the checklists in electronic format that permits users to: load them onto computers and use as is, modify them by adding users' own questions, complete the checklists and store as an electronic record, and print all checklists.

Computer requirements: Windows 95, 98, or NT. The software can be installed on laptops, single-user stations, or a network (but is enabled for only one user at a time).

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