Managing the Documentation Maze

Answers to Questions You Didn't Even Know to Ask
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.
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. 

UK Delivery:

• Free delivery on all orders of £10 or more.
• £1.49 delivery fee on orders below £10.
• UK orders are shipped via Royal Mail 2nd Class.

International Delivery:

• Flat rate delivery charges vary by country.

Dispatch and Delivery Times:

• All orders are shipped from our warehouse in Northampton, UK within 48 hours of receipt during working hours.
• UK mainland orders typically arrive within 3-5 working days via Royal Mail 2nd Class.
• International estimated delivery times:
• Europe & Channel Islands: 7 to 10 working days
• USA: 7 to 15 working days
• Rest of the World: 9 to 21 working days

View our full delivery infomation here.