Chromatographia

, Volume 55, Supplement 1, pp S85–S90 | Cite as

The impact of 21 CFR 11 (Electronic records and electronic signatures final rule) on bioanalysis

  • R. D. McDowall
Article

Summary

The impact of 21 CFR 11 on bioanalysis is discussed. The main requirements of the regulation are summarised in overview and the impact of these requirements on bioanalytical laboratories are discussed. To benefit fully from the requirements in 21 CFR 11, electronic signatures should be implemented after redesigning the process to take advantage of their use.

Key Words

Electronic records Electronic signatures 21 CFR 11 

References

  1. [1]
    21 CFR 11, Electronic Records and Electronic Signatures Final Rule,Federal Register 1997,62, 13430–13466, Washington DC.Google Scholar
  2. [2]
    McDowall, R.D.,LC-GC Europe,2000,13, 331–336, 338, 339.Google Scholar
  3. [3]
    McDowall, R.D.LC-GC Europe,2000,13, 734, 736, 738, 740, 742.Google Scholar
  4. [4]
    McDowall, R.D.LC-GC Europe 2001,14, 98, 100, 102, 104.Google Scholar
  5. [5]
    Compliance Policy Guide 7153.17,Federal Register 1999,64, 41442–41443, Washington DC.Google Scholar
  6. [6]
    McDowall, R.D.LC-GC Europe,2000,13, 648–653.Google Scholar

Copyright information

© Friedr. Vieweg & Sohn Verlagsgesellschaft mbH 2002

Authors and Affiliations

  • R. D. McDowall
    • 1
  1. 1.McDowall ConsultingBromleyUK

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