While everyone has heard about giant companies such as Wal-Mart and General Motors, Fortune magazine occasionally runs articles about huge companies that most people don't know of. Similarly, in the information security space, many people have heard of regulations such as Common Criteria, ISO-17799 and HIPAA. Yet there is a huge regulation that many people know nothing of, namely 21 CFR Part 11.Title 21 Part 11 of the U.S. Code of Federal Regulations (also known as 21 CFR Part 11 or simply Part 11) falls under the authority of the United States Food and Drug Administration (FDA). The FDA felt that the risks of falsification, misinterpretation and change without leaving evidence are higher with electronic records than paper records and therefore specific controls are required.
Part 11 deals with the conditions under which the FDA will accept electronic records and electronic signatures as equivalent to paper records and handwritten signatures and electronic New Drug Application (NDA) submissions as equivalent to paper submission.
With that, 21 CFR Part 11: Complete Guide to International Computer Validation is a very good overview of the topic.
The book details how organizations regulated by Part 11 can create a compliance strategy for validated systems.
Anyone needing a quick introduction to Part 11 will find this work valuable.
The only negative to this book is its price; at $180.00, it is extremely expensive.Such a price will make the book unobtainable for most readers.I believe its low Amazon.com Sales Rank of 1,810,979 is due directly to that.
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