SPIFAN MCPD/GE ERP New Member Book
OMB Expectation Parameters
Comparison to Standard/ Acceptance Criteria
Single Laboratory Validation
Reproducibility/ Uncertainty
Documented method performance versus a SMPR, recognized reference standard (materials), recognized reference method, or general method end user community guidance and/or acceptance criteria
Qualitative methods: inclusivity (or equivalent), exclusivity (or equivalent), robustness, repeatability, POD (or equivalent), cross reactivity, matrix scope, etc…
Qualitative methods: - probability of detection or equivalent
Quantitative methods: demonstrated method linearity, accuracy, repeatability, selectivity, LOD/LOQ, Matrix scope, etc….
Quantitative methods: demonstrated method reproducibility and/or uncertainty
Document reasons for acceptability if it doesn’t meet the standard or acceptance criteria
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