An Easy to Understand Guide to 21 CFR Part 11
If you've decided to invest some time in reading this book, I am making the assumption that you are pretty tired of wading through the regulations developed by the FDA that were designed to confuse the hell out of everyone!
Our easy to understand guide is the ultimate solution to guide you through all of these regulations in a clear and concise manner.
What Will You Learn?
The book will teach you all you need to know about 21 CFR Part 11.21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration's (FDA) guidelines on using electronic records (e-recs) and electronic signatures (esigs).
Part 11, as it's commonly called, defines the criteria under which electronic records and electronic signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper. Currently, the scope of this regulation is all FDA program areas.
Who Should Read This Book?
At around 72 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 21 CFR Part 11 or want to brush up on your current knowledge this book is made for you!
We’ve broken down this book into five key sections:
- The Starting Point
- E-Sigs and E-Recs Explained
- General Rules of System Access
- E-Signatures
- Documentation and Regulatory Controls
- The Difference between Open and Closed Systems
- Computer System Validation
- Audit Trails
- E-Records
- Hybrid and Legacy Systems
Why buy from Premier Validation?
Of course, we’re so confident that you’ll be happy with this book for years to come that we’re happy, as always, for you to try it risk-free for 30 days. If you purchase a copy of An Easy to Understand Guide to 21 CFR Part 11 and you think it falls short of being everything you wanted, we’d like you to have your money back.
Simply contact us and we’ll see to it that you receive a prompt refund of the full purchase price, minus shipping and handling.
What could be fairer than this?
