21 CFR Part 11 and the Role of the Hand-Held Terminal

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21 CFR part 11 compliance is a critical issue currently facing the pharmaceutical, biogen, and life sciences markets. The electronic signature requirement may expand to adjacent markets that deal with human consumables. At the lowest levels, data is entered via pen and paper with a physical signature. In this paper we discuss extending the electronic signature down to the portable hand-held terminal level to completely eliminate organic signatures and the advantages and challenges associated with this extension.

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