Write It Down: Guidance for Preparing Effective and Compliant Documentation

A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective documentation in place. The book has a three-pronged focus: to help writers understand the why of what they must write and the current industry standards for good documentation practices, to provide effective examples of a broad spectrum of documents, and to supply an in-depth explanation of grammar and punctuation conventions. 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.

The Simple Present Tense.

Front cover -- Table of Contents -- DEDICATION -- INTRODUCTION -- About the Author -- Acknowledgments -- Chapter 1 -- Writing Within the Regulated Environment -- Writing for Compliance with Binding Regulations -- Document, Document, Document -- Keeping the House in Order -- Document Control -- Standard Formats -- The Writing Task -- Writing and Revising -- Collaborative Writing -- The First Approach -- The Second Approach -- Reaching Agreement -- First Draft/Idea Stage -- 2nd Draft: Expanded Text -- Final Draft -- Document Formal Review -- Serving as a Reviewer -- The Writer's Voice -- Making Comments -- Three unknowns are inherent. -- Three unknowns are innate. -- "Confusing. Rewrite!!" -- Guidelines for Reviewing Documents -- Serving as Author During Document Review -- Considering the Effects of Diversity -- Setting Priorities for Writing -- Chapter 2 -- Connecting Writer and Reader -- Readers' Language Skills -- What Is Informed Consent? -- When Is Informed Consent Needed? -- Who Can Give Informed Consent? -- Tips for Writing Informed Consent -- Writing Directly to the Reader -- A Preventive Maintenance Memo -- Original -- Rewrite -- Announcing an Inspection -- Announcing a GMP…