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.
What Will You Learn?
Software validation can encompass a wide range of software applications ranging from very simple to very complex. In many regulated environments, both product software and software that could impact product software quality are expected to be validated. Product software ranges from embedded, real-time applications to desktop analysis applications, to web-based image processing applications. Boiled down, though, the intent is the same for all applications.
Who Should Read This Book?
At around 73 pages, this book is an easy read. As you move through the book you’ll quickly notice that it’s written in a clear tutorial format that’s easy to understand. If you hate wading through dry “academic-style how to” texts, this book will be a breath of fresh air to you. If you want to learn about software validation protocols or want to brush up on your current knowledge this book is made for you! We’ve broken down this book into 9 key sections:
- Scope
- Documentation Infrastructure
- Getting Organized
- Protocol Development
- Preparing for and Executing the Protocols
- Recording Results
- Test Development Considerations
- Protocol Types
- Other Protocol Formats
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