This book covers writing for the FDA as it applies to the pharmaceutical industry. It presents a brief overview of the regulatory environment and documentation requirements, identifies the roles of writers and readers, and discusses the purpose of good documentation. The book offers a documents and representative writing samples from throughout the industry, ranging from the laboratory to Quality Assurance to manufacturing and regulatory affairs. It provides writers with the tools they need to complete writing tasks effectively. This new edition includes examples of various forms of...
This book covers writing for the FDA as it applies to the pharmaceutical industry. It presents a brief overview of the regulatory environment and docu...
The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic Record Keeping: Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 explores how to evaluate, select, implement, and document an e-system that will keep your organization in compliance. Covering Title 21 of the Code of Federal Regulations (CFR) Part 11 and the parallel,...
The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf s...
