In March 1997, the Food & Drug Administration (FDA) issued the final Part 11 regulations providing FDA acceptance criteria when under certain circumstances electronic records, electronic signatures, and handwritten signatures executed to electronic records are equivalent to paper records and handwritten signatures executed on paper. In March 2004, the FDA released its final rule requiring bar codes on drug and biological products. The final rule applies to most drug manufacturers, re-packers, re-labelers, private label distributors and blood establishments. This white paper introduces some of the FDA regulation 21 CFR (Code of Federal Regulation) Part 11 and discusses how Label Gallery enables you to meet these requirements.
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