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Last modified: 2024-07-23 
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PyroButton Sterilization Process Management



DQ-IQ-OQ-PQ

DQ supports the functional & quality specifications designed into PyroButton. Documentary proof of DQ compliance includes:

  • IQ-OQ-PQ protocols
  • 21 CFR Part 11 Verification Summary,
  • Measurement Performance Design Summary, and
  • NIST Traceable Calibration Summary


IQ (Installation Qualification) - IQ supports the requirement for proper installation and acceptance qualification for PyroButton. Documentary proof of IQ compliance includes:

  • Receipt & acceptance checklist,
  • Physical & electrical compliance checklist,
  • Environmental compliance checklist,
  • Training compliance checklist, and
  • Final IQ Summary


OQ (Operational Qualification) - OQ supports the specification compliant functioning of the system. Documentary proof of OQ compliance includes:

  • 21 CFR Part 11 operational specification checklist,
  • Software operational specification checklist,
  • Instrument interface operational specification checklist,
  • Instrument operational specification checklist, and
  • Final OQ Summary


PQ (Performance Qualification) - PQ supports quality evaluation & quality compliance management of the system. PQ compliance models include:

  • 21 CFR Part 11 compliance models,
  • Simulation models for data-acquisition optimization, and
  • SQC models for measurement qualification review.



   



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