This book provides hands-on techniques for writing engineering procedures to achieve ISO 9000 compliance. It is designed for individuals responsible for writing these procedures in any industry. Readers will find actual examples of clearly written, compliant engineering procedures, ready to adapt to your own industry and your own particular needs and use immediately. It answers virtually all your procedure writing questions.

Procedure writers will gain a general understanding of engineering documentation principles and how to apply them to their own situations. Simple diagrams and other...

While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough...

Explains in detail how to develop and manage qualification protocols and their associated documentation for all of the validation department functions Shows how to perform qualification testing and establish a requalification program Describes how various documents relate to each other and to an overall documentation system Discusses in details key function areas, such as Cleaning, Facilities and Utilities, Equipment, Computers and Software, and Process Provides ready-to-use protocols and protocol templates All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good...

This handbook is a new systematic approach to engineering documentation, therefore, it will simplify the end users ability to set up or enhance their engineering documentation requirements. Companies with small manual systems to large-scale mass production facilities can use this handbook to tailor their engineering documentation requirements.

If an individual or company wishes to create or improve an engineering documentation system, there is no need to start from scratch. Instead, use this new handbook, complete with 47 specially designed forms and with procedures that cover every major...