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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 and Access 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 of Hitachi ID Systems of the relevance of this legislation to information security, and to identity management in particular.

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