Managing the Documentation Maze (PDF)

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.