Touchstone & 21 CFR 11

Touchstone has extensive experience with 21 CFR 1, since 1992 as follows:

  • “Beta” Testing of guidance before it was rolled out to industry
  • Commenting on guidance before rolled out to industry
  • Leading the industry in implementation of guidance (through membership in CVIC)
  • Papers on 21 CFR 11 implementation in industry journal
  • Co-authorship of publications with DIA and FDA on 21 CFR 11 implementation in industry:
    • “Red Apple” Book: Computerized Systems used in Non-Clinical Safety Assessment: Current Concepts in Validation & Compliance
    • “Peach” Book: Computerized Systems in Clinical Research: Current Data Quality & Data Integrity Concepts.
  • Training of FDA personnel in 21 CFR 11
  • Assisting the FDA with evolution of 21 CFR 11
  • Patent in speeding up Computer Systems Validation (21 CFR 11.10(a))

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