Test system definition documents

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Test system definition (Quantitative response assay)
.... Name
.... Identification
.... Date
.... Source
........ Config
............ Update mode
.... Creation time
.... Suitability tests
........ Assay suitability tests
............ Alternatives
................ F-test (hypothesis test)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Type
.................... Alternatives
........................ Confidence level (%)
........................ p
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Equivalence test: Parameter estimate
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Parameter
.................... Upper margin
.................... Lower margin
.................... Confidence level (%)
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Equivalence test: Difference of parameter estimates
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Parameter
.................... Upper margin
.................... Lower margin
.................... Confidence level (%)
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Equivalence test: Ratio of parameter estimates
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Parameter
.................... Upper margin
.................... Lower margin
.................... Confidence level (%)
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Equivalence test: Scaled parameter range
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Parameter
.................... Upper margin
.................... Lower margin
.................... Scaling parameter
.................... Confidence level (%)
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Point estimate test: Parameter estimate
.................... Parameter
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Point estimate test: Difference of parameter estimates
.................... Parameter
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Point estimate test: Ratio of parameter estimates
.................... Parameter
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Normalized difference of asymptotes
.................... Parameter
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Sum of squares regression
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Sum of squares non-parallelism
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Sum of squares non-linearity
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Extent of the test
.................... Rounding
................ Test: Ratio sum of squares non-linearity / sum of squares regression
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Potency value
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Potency type
.................... Rounding
................ Test: Potency confidence interval
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Potency type
.................... Rounding
................ Test: Log potency range (L-value)
.................... Parameter
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Potency of intermediate dilution
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... No. of dilution factor
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Potency confidence interval (%)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Potency range (%)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Weight (W)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Maximal number of outliers
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Extent of the test
................ Test: Maximal sequence step CV (%)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Minimal R²
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Extent of the test
.................... Rounding
................ Test: Relative LOF error (%)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Response value range
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Root mean square error (RMSE)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Extent of the test
.................... Rounding
........ Sample suitability tests
............ Alternatives
................ F-test (hypothesis test)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Type
.................... Alternatives
........................ Confidence level (%)
........................ p
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Equivalence test: Parameter estimate
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Parameter
.................... Upper margin
.................... Lower margin
.................... Confidence level (%)
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Equivalence test: Difference of parameter estimates
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Parameter
.................... Upper margin
.................... Lower margin
.................... Confidence level (%)
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Equivalence test: Ratio of parameter estimates
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Parameter
.................... Upper margin
.................... Lower margin
.................... Confidence level (%)
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Equivalence test: Scaled parameter range
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Parameter
.................... Upper margin
.................... Lower margin
.................... Scaling parameter
.................... Confidence level (%)
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Point estimate test: Parameter estimate
.................... Parameter
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Point estimate test: Difference of parameter estimates
.................... Parameter
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Point estimate test: Ratio of parameter estimates
.................... Parameter
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Normalized difference of asymptotes
.................... Parameter
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Sum of squares regression
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Sum of squares non-parallelism
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Sum of squares non-linearity
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Extent of the test
.................... Rounding
................ Test: Ratio sum of squares non-linearity / sum of squares regression
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Potency value
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Potency type
.................... Rounding
................ Test: Potency confidence interval
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Potency type
.................... Rounding
................ Test: Log potency range (L-value)
.................... Parameter
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Potency of intermediate dilution
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... No. of dilution factor
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Potency confidence interval (%)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Potency range (%)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Weight (W)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Maximal number of outliers
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Extent of the test
................ Test: Maximal sequence step CV (%)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Minimal R²
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Extent of the test
.................... Rounding
................ Test: Relative LOF error (%)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Response value range
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Lower margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Rounding
................ Test: Root mean square error (RMSE)
.................... Test name
.................... Conditional evaluation
........................ Test reference
........................ Evaluation condition
.................... Upper margin
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
.................... Severity level of the test
.................... Extent of the test
.................... Rounding
........ Document suitability tests
............ Signature state
................ Number of signatures
................ Meaning
................ Scope of the test
................ Severity level of the test
............ Test on user variable
................ Key
................ Value
................ Severity level of the test
.... Comment
........ Subject
........ Text
........ Linked document
........ Date
........ Author