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Innovative in spite of regulations

With zenon, not only can you control, monitor, and optimize the production process, but you can also efficiently meet the provisions of numerous regulations for pharmaceutical manufacturers, because solutions with zenon meet international regulations such as FDA 21 CFR Part 11 or Annex 11 of the EU GMP guidelines. The best thing about it: in zenon compliance is available out-of-the-box.

FDA Part11 Regulated Industries zenon EU GMP Annex 11 Compliance 20

What is inside the FDA-eBook?

  • What FDA 21 CFR Part 11 requires
  • How zenon complies with Subpart B Electronic Record
  • How zenon complies with Subpart C Electronic Signatures

What is inside the Annex 11-eBook?

  • What EU GMP Annex 11 requires
  • How zenon complies with the requirements throughout the system lifecycle

About COPA-DATA

  • 20+ years of SCADA/HMI solutions in the pharmaceutical industry
  • 5,000+ customers worldwide
  • Utilized in 50+ countries

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