Substantially expanded, the second edition focuses on the regulations, the need to document, and the range of documentation that must be in place to support therapeutic products from discovery through market. Readers will find useful examples of good writing, many provided by people in the industry. Letters and memos; short reports of varied topics, including equipment evaluation, vendor audit, and trip review; standard operating procedures, laboratory methods, and training materials; documentation for an IQ/OQ/PQ project; a journal article; and excerpts from a development report and a dossier are among the many examples. The book also gives a thorough explanation of grammar, punctuation, and usage, with a strong emphasis on the components of the language that pose difficulties for non-native writers of English.
This book is a must for people working in or preparing to work in environments that produce drugs, medical devices, or biologics for sale in countries that have stringent regulatory requirements and where the business language is English. Firmly placing the writing task in context of the existing laws and guidances, the book offers valuable insights into managing systems and producing documentation that meets the requirements of the binding regulations.
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 keepingElectronic systems, hybrid systems, and the entire scope ofdocumentation that companies must manageHow to write and edit documents that meet regulatorycomplianceMaking 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.