Managing the Documentation Maze (eBook)

Answers to Questions You Didn't Even Know to Ask

Janet Gough, David Nettleton (Autoren)

eBook Download: PDF

2010 | 1. Auflage
488 Seiten
John Wiley & Sons (Verlag)
9780470597491 (ISBN)

Infos

The accessible, easy-to-follow guide that demystifies
documentation management

When it comes to receiving documentation to confirm good
science, U.S. and international regulators place high demands on
the healthcare industry. As a result, companies developing and
manufacturing therapeutic products must implement a strategy that
allows them to properly manage their records and documents, since
they must comply with rigorous standards and be available for
regulatory review or inspection at a moment's notice.

Written in a user-friendly Q&A style for quick reference,
Managing the Documentation Maze provides answers to 750
questions the authors encounter frequently in their roles as
consultants and trainers. In simple terms, this handy guide breaks
down the key components that facilitate successful document
management, and shows why it needs to be a core discipline in the
industry with information on:

* Compliance with regulations in pharmaceutical, biological, and
device record keeping

* Electronic systems, hybrid systems, and the entire scope of
documentation that companies must manage

* How to write and edit documents that meet regulatory
compliance

* Making the transition to an electronic system, including how to
validate and document the process

Anyone responsible for managing documents in the health field
will find this book to be a trusted partner in unraveling the
bureaucratic web of confusion, while it initiates a plan on how to
put an effective, lasting system in place--one that will stand
up to any type of scrutiny.

Autor

Janet Gough has extensive experience as a consultant to the pharmaceutical, biotech, and medical device industries. She designs systems for compliance with binding regulations, and conducts training accordingly. She assists companies in the preparation of documents including development reports, procedures, clinical documents, and regulatory fillings. Ms. Gough is the author of seven other books. David Nettleton is a compliance, documentation, and computer system validation consultant involved with the development, purchase, installation, operation, project management, and maintenance of computerized systems used in regulated applications (GMP, GCP, and GLP). He is the author of three other books.

Inhalt

INTRODUCTION.

ABOUT THE AUTHORS.

CHAPTER 1 UNDERSTANDING THE REGULATIONS.

CHAPTER 2 PEOPLE, PROCESS, AND DOCUMENTATION.

CHAPTER 3 PRINCIPLES OF DOCUMENT MANAGEMENT.

CHAPTER 4 DECIDING TO GO ELECTRONIC AND FINDING A VENDOR.

CHAPTER 5 MAKING THE TRANSITION FROM HYBRID TO VALIDATED
E-SYSTEM.

CHAPTER 6 PART 11 COMPLIANCE.

CHAPTER 7 STANDARD OPERATING PROCEDURES.

CHAPTER 8 NONCLINICAL RECORDS.

CHAPTER 9 CLINICAL AND SUBMISSION RECORDS.

CHAPTER 10 CONSISTENCY AND READABILITY IN DOCUMENTS.

CHAPTER 11 MAINTAINING THE SYSTEM.

CHAPTER 12 MAINTAINING INSPECTION READINESS.

CHAPTER 13 RESOURCES.

APPENDIX.

FEDERAL REGISTER.

GUIDANCE FOR INDUSTRY.

INDEX.

Rezensionen

"Managing the Document Maze takes a fascinating and extremely
effective approach to its topic . . . this organisational framework
makes it very easy to target information that will answer specific
questions of interest to the reader, while also providing a
comprehensive overview of key information . . .Managing the
Document Maze is recommended to readers, and receives the JCS
Library Award." (Journal for Clinical Studies, 1 July 2010)



"Managing the Documentation Maze is an excellent reference
source in an easy-to-follow Q&A format for all healthcare
professionals involved in the drug discovery process, development
and manufacture of therapeutic products. Questions regarding all
aspects of document management, validation, regulatory compliance,
transition to electronic systems are clearly answered is an
uncomplicated style by the authors, based on their extensive
industry experience. I would, therefore, highly recommend this
handy guide to all healthcare professional as 'Aide-mémoire',
to quickly resolve and comply with rigorous regulatory standards
required of the industry today."

--Tom Blackburn, TPBioventures, LLC

Produkt-Details

• Erscheint lt. Verlag: 5.5.2010
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Gesundheitswesen
• Themenwelt: Naturwissenschaften ► Chemie
• Themenwelt: Wirtschaft ► Betriebswirtschaft / Management ► Unternehmensführung / Management
• Schlagworte: Chemie • Chemistry • Drug Discovery & Development • Pharmazeutische Industrie • Qualitätssicherung • Qualitätssicherung in der Chemie • Qualitätssicherung • Qualitätssicherung in der Chemie • Quality assurance • Wirkstoffforschung u. -entwicklung
• ISBN-13: 9780470597491 / 9780470597491