This document gives a brief introduction to Title 21 of the Code of Federal Regulations, Volume 11 (21 CFR 11 for short), and describes how it impacts information security in the pharmaceutical industry.
The Hitachi ID Identity Management Suite™ is then introduced, and its use to comply with the requirements set forth in 21 CFR 11 is described.
Please note that this document does not constitute legal advice, or a legal interpretation of 21 CFR 11. This document represents the best understanding by Hitachi ID of the relevance of this legislation to information security, and to identity management in particular.
13. Using The Hitachi ID Management Suite to Comply with 21 CFR 11
6 Summary
As described in this document, 21 CFR 11 introduces formal requirements for companies, such as pharma-
ceuticals, that must provide signed electronic documents to the FDA.
The Hitachi ID identity management suite includes robust, secure, scalable and deployable technology to
implement identity management processes that meet these requirements.
www.Hitachi-ID.com
500, 1401 - 1 Street SE, Calgary AB Canada T2G 2J3 Tel: 1.403.233.0740 Fax: 1.403.233.0725 E-Mail: sales@Hitachi-ID.com
File: /pub/wp/idsynch/documents/21cfr11/mtech-21cfr11-1.tex
Date: November 22, 2003