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

Description

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):