Computer Systems Validation Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies pdf

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Computer Systems Validation Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies by Guy Wingate pdf

Computer Systems Validation Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies by Guy Wingate pdf free download. This book was prompted by an invitation to prepare a second edition of my first book on computer validation, Validating Automated Manufacturing and Laboratory Applications. On first reflection, it seemed that there might be little to update, but on further scrutiny I realized there have been considerable developments since 1997, not the least of which are new regulatory requirements for electronic records and electronic signatures. All this has led to a significant update with much new 19 through 42) consists of case studies contributed by highly experienced industry experts examof risk management throughout the life cycle of a computer system is emphasized not only for the benefit of patient/consumer safety but also in terms of cost-effectiveness.

Computer Systems Validation Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies by Guy Wingate pdf

Throughout the book I have added real observations recently made by the FDA on the various topics being discussed. I owe special thanks to those friends and colleagues who have provided invaluable discussions and explorations of computer validation principles and practices over the years. Validation in the real world is rarely simple and straightforward. My wish is that this book will enjoy equal success with its predecessor in sharing practical solutions to the many and varied challenges that face validation practitioners.

Computer Systems Validation Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies by Guy Wingate pdf

In addition to the case study contributors listed, I would particularly like to add my thanks to Sam Brooks (ABB), Ellis Daw (GlaxoSmithKline), Paul DíEramo (Johnson & Johnson), Howard Garston-Smith (Garston Smith Associates), Jerry Hare (GlaxoSmithKline), Scott Lewis (Eli Lilly), Takayoshi Matsumura (Eisai), Gordon Richman (EduQuest), David Selby (Selby-Hope), Amanda Willcox (GlaxoSmithKline), and Sion Wyn (Conformity). I am hugely indebted to Ellis Daw, Chris Reid, and especially Howard Garston-Smith and Christine Andreasen (CRC Press) for their proofreading of chapters in this book.

Computer Systems Validation Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies by Guy Wingate pdf

They have not only helped improve my grammar but have also prompted inclusions of additional material to better explain some of the validation concepts discussed. Finally, once more I am indebted to Sarah, my wife, and our family for their love, patience, and support during the preparation of this book. Those who have read my two previous books on computer validation know that my books seem to coincide with the arrival of a new baby in our family. So it is with this book, and I am delighted to include Edward in the dedication.

Computer Systems Validation Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies by Guy Wingate pdf

Computer Systems Validation Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies by Guy Wingate pdf

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