An Easy to Understand Guide to Annex 11
The usual reaction when someone brings up the term Annex 11 is that people just gloss over it and focus on what they deem more important, which is 21 CFR Part 11. However if you work in a facility that is not manufacturing product for the US market, but for the European market then Annex 11 is the regulation you must adhere to.
What Will You Learn?
This book examines the released final version of Annex 11 for computerized systems and provides my recommendations to implement Annex 11. There are many other ways to implement the same requirements. For the purpose of bringing up to the reader additional information, it is referenced relevant regulations/guidelines.
The purpose of this book is not to find gaps between Annex 11 and the referenced regulations. Some descriptions are based on listed guidelines with judicious editing were necessary to fit the context of this book.
Who Should Read This Book?
At around 76 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 Annex 11 or want to brush up on your current knowledge this book is made for you!
We’ve broken down this book into seventeen key sections:
- Risk Management
- Personnel
- Suppliers and Service Providers
- Validation
- Data
- Accuracy Checks
- Data Storage
- Printouts
- Audit Trails
- Change and Configuration Management
- Periodic Evaluation
- Security
- Incident Management
- Electronic Signatures
- Batch Release
- Business Continuity
- Archiving
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 Annex 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?
