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Managing the documentation maze : answers to questions you didn't even know to ask / Janet Gough, David Nettleton.
- Format:
- Book
- Author/Creator:
- Gough, Janet.
- Language:
- English
- Subjects (All):
- Medical records--Automation.
- Medical records.
- Medical records--Data processing.
- Physical Description:
- 1 online resource (486 p.)
- Edition:
- 1st edition
- Place of Publication:
- Hoboken, N.J. : Wiley, c2010.
- Language Note:
- English
- System Details:
- Mode of access: World Wide Web.
- text file
- Summary:
- 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 Doc
- Contents:
- MANAGING THE DOCUMENTATION MAZE; CONTENTS; 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 READINESSCHAPTER 13 RESOURCES; APPENDIX; FEDERAL REGISTER; GUIDANCE FOR INDUSTRY; INDEX
- Notes:
- Includes index.
- Includes bibliographical references and index.
- Description based on metadata supplied by the publisher and other sources.
- ISBN:
- 9786612549908
- 9781282549906
- 1282549901
- 9780470597507
- 047059750X
- 9780470597491
- 0470597496
- OCLC:
- 587063588
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