Risk-based Software Validation: Ten Easy Steps

This book offers a systematic, ten-step approach, from the decision to validate to the assessment of the validation outcome, for validating configurable off-the-shelf (COTS) computer software that generates data or controls information about products and processes subject to binding regulations. COTS software validation often is a time-consuming process in which a great deal of effort is spent determining the necessary validation tasks and the content and format of the validation documents. This book provides the templates and explains how to get from start to "go live" in the most time-efficient way. It is a tool to help industry professionals effectively validate the systems they need to move their businesses forward. This book comes with CD that provides with templates.

David Nettleton is a 21 CFR Part 11 Specialist and Computer System Validation consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. Services include gap analysis remediation plans, SOP development, vendor audits, training, and project management. David has completed more than 150 computer system validation projects for mission critical applications involving blood bank, clinical trial, corrective action, document control, electronic data capture, Excel spreadsheets developed for regulated applications, Internet billing, laboratory instruments, laboratory information management, manufacturing enterprise resource planning, medical device software, MRI software, nuclear power plant maintenance, pharmaceutical, retail software including Visio and MS Windows operating systems, server room moves, toxicology systems, and environmental monitoring.

Janet Gough has extensive experience as a consultant to the pharmaceutical and medical device industries. She designs systems for compliance with 21 CFR 211, 21 CFR 820, 21 CFR 58, and the International Conference on Harmonization (ICH.) She assists companies in the preparation of documents including research and development reports, procedures, clinical documents, and regulatory filings. She also writes and edits journal articles, trains staff in English as a Second Language as well as technical writing. She has been a director of technical communications for a biotechnical company, and has taught English in university graduate and undergraduate programs. She is the author of Write It Down: Guidance for Preparing Effective and Compliant Documentation, Second Edition and Hosting a Compliance Inspection (Davis Healthcare International and PDA), and is the co-author of The Internal Quality Audit and The External Quality Audit (Davis Healthcare International and PDA.) Previous title written by these two authors: Commercial OFF-The-Shelf Software Validation for 21 CFR Part 11 published in 2003.