Managing the Documentation Maze

The accessible, easy-to-follow guide that demystifiesdocumentation management
When it comes to receiving documentation to confirm goodscience, U.S. and international regulators place high demands onthe healthcare industry. As a result, companies developing andmanufacturing therapeutic products must implement a strategy thatallows them to properly manage their records and documents, sincethey must comply with rigorous standards and be available forregulatory 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 750questions the authors encounter frequently in their roles asconsultants and trainers. In simple terms, this handy guide breaksdown the key components that facilitate successful documentmanagement, and shows why it needs to be a core discipline in theindustry with information on:
* Compliance with regulations in pharmaceutical, biological, anddevice record keeping
* Electronic systems, hybrid systems, and the entire scope ofdocumentation that companies must manage
* How to write and edit documents that meet regulatorycompliance
* Making the transition to an electronic system, including how tovalidate and document the process
Anyone responsible for managing documents in the health fieldwill find this book to be a trusted partner in unraveling thebureaucratic web of confusion, while it initiates a plan on how toput an effective, lasting system in place--one that will standup to any type of scrutiny.