PHDS Co.
Software

WinOMNI-GMP: 21 CFR Part 11 compliance for WinOMNI analysis

WinOMNI-GMP brings WinOMNI analysis into a 21 CFR Part 11 environment: complete audit trails, user access controls, electronic signatures, and tamper-evident records, so your measurements meet the requirements of GMP production.

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Key Features
  • Complete audit trail: every action recorded with user and timestamp
  • Role-based user access controls and electronic signatures
  • Tamper-evident records and compliant reporting for batch release
Application Areas
Radiopharmaceutical
Radiopharmaceutical production QA and quantified radionuclidic purity performed with GMP and 21 CFR Part 11 compliant software
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Radiochemistry
Monitor radioisotope separations as they happen, with real-time HPGe gamma-ray imaging and bench-scale quantification.
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Works With
WinOMNI Spectral View
WinOMNI
The Windows analysis platform for the Fulcrum line: isotope ID, quantification, uncertainty, and defensible reporting.
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Next steps

Questions about the WinOMNI-GMP?

Our application engineers can help scope your measurement requirements, confirm detector performance for your specific isotopes, and recommend the right configuration.

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