TRACERcenter 212 

For facilities in the U.S. affected by 21 CFR part 212, TRACERcenter 212 includes a five-module process to specifically address and help you comply with U.S. regulations. The 212 program offers a complete and integrated GMP equipment, service, and support platform to help enable your facility’s compliance.


This quality and regulatory assurance program is specifically designed for facilities operating in the U.S., and subject to 21 CFR part 212.  The program includes five modules that address:

  • Design Review
  • Quality Management System
  • Facility and Process Management Qualification
  • Onsite IQ/OQ execution
  • Generic Dossier for FDG submission



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