An Easy to Understand Guide to Equipment Qualification
This book describes how to perform the qualification assessment depending upon the impact of individual equipment on product quality. The risk based qualification assessment describes the qualification steps (RA,DQ, IQ, OQ, PQ etc.) required to qualify the equipment. This approach eliminates the duplication of effort and costly practices.
An Easy to Understand Guide to Validating Purified Water Systems
This quick and easy guide describes how to design, build, and validate a purified water treatment system according to current quality regulations and standards. You will find this guide especially helpful if you are in the planning phase for a new purified water treatment system, interested in upgrading your current system and new to water treatment projects.
This quick and easy guide describes methods and approaches for writing a validation protocol that can help ensure a thorough validation effort. It also provides some tips and tricks on executing the protocol and documenting the results. While this book was written primarily for those new to validation projects and the effort required gathering sufficient evidence to support validation claims, experienced folks will likely find nuggets to help improve their efforts.
Edited by Tim Sandle and Madhu Raju Saghee.
ISBN 978-0-9573491-6-2 (Hb) ISBN 978-0-9956666-0-3 (Pb)