Managing the Documentation Maze : Answers to Questions You Didn't Even Know to Ask

**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. Content: Chapter 1 Understanding the Regulations (pages 1–28): Chapter 2 People, Process, and Documentation (pages 29–45): Chapter 3 Principles of Document Management (pages 47–68): Chapter 4 Deciding to go Electronic and Finding a Vendor (pages 69–96): Chapter 5 Making the Transition from Hybrid to Validated E?System (pages 97–119): Chapter 6 Part 11 Compliance (pages 121–140): Chapter 7 Standard Operating Procedures (pages 141–159): Chapter 8 Nonclinical Records (pages 161–171): Chapter 9 Clinical and Submission Records (pages 173–202): Chapter 10 Consistency and Readability in Documents (pages 203–221): Chapter 11 Maintaining the System (pages 223–237): Chapter 12 Maintaining Inspection Readiness (pages 239–253): Chapter 13 Resources (pages 255–258): MANAGING THE DOCUMENTATION MAZE......Page 4 CONTENTS......Page 8 INTRODUCTION......Page 10 ABOUT THE AUTHORS......Page 12 CHAPTER 1 UNDERSTANDING THE REGULATIONS......Page 14 CHAPTER 2 PEOPLE, PROCESS, AND DOCUMENTATION......Page 42 CHAPTER 3 PRINCIPLES OF DOCUMENT MANAGEMENT......Page 60 CHAPTER 4 DECIDING TO GO ELECTRONIC AND FINDING A VENDOR......Page 82 CHAPTER 5 MAKING THE TRANSITION FROM HYBRID TO VALIDATED E-SYSTEM......Page 110 CHAPTER 6 PART 11 COMPLIANCE......Page 134 CHAPTER 7 STANDARD OPERATING PROCEDURES......Page 154 CHAPTER 8 NONCLINICAL RECORDS......Page 174 CHAPTER 9 CLINICAL AND SUBMISSION RECORDS......Page 186 CHAPTER 10 CONSISTENCY AND READABILITY IN DOCUMENTS......Page 216 CHAPTER 11 MAINTAINING THE SYSTEM......Page 236 CHAPTER 12 MAINTAINING INSPECTION READINESS......Page 252 CHAPTER 13 RESOURCES......Page 268 APPENDIX......Page 272 FEDERAL REGISTER......Page 274 GUIDANCE FOR INDUSTRY......Page 444 INDEX......Page 464

this Book Deals With A Topic Of Critical Importance For Compliance With Record-keeping Regulations In Pharmaceutical And Medical Device Industries. It Presents More Than 750 Questions And Answers About Documentation Management, Whether Electronic Or Paper-based. It Defines, Through A Q&a Approach, What Document Management Actually Is, And Why It Should Be A Core Discipline In The Industry. Questions And Responses Also Address Electronic System Selection And Validation, System Security, User Accountability, And Audit Trails, As Well As Standard Operating Procedures For Supporting Document Systems. Finally, Responses Demystify The Meaning Of Binding Regulations.

This book deals with a topic of critical importance for compliance with record-keeping regulations in pharmaceutical and medical device industries. It presents more than 750 questions and answers about documentation management, whether electronic or paper-based. It defines, through a Q & A approach, what document management actually is, and why it should be a core discipline in the industry. Questions and responses also address electronic system selection and validation, system security, user accountability, and audit trails, as well as standard operating procedures for supporting document syste