QbDVision API Objects
Table of Contents
Product Objects
Drug Substance
Editable Name: DrugSubstance
UI Attribute | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (DS) and the ID. |
Name | name | - |
CTD Filed Name |
| - |
Description | description | - |
Internal Part Number | internalPartNumber | - |
Source Documents | links | An array of encoded JSON objects in the format of Source Documents. |
Output | DrugSubstanceFlows[flow=Output].* | Drug Substance objects are limited to |
Attributes | DrugSubstanceToFQAs[*] | An array of encoded JSON objects representing links to FQAs and IQAs. |
Tags | tags | An array of encoded JSON objects. |
Drug Substance Type | drugSubstanceType | - |
Form | form | - |
Density | density | - |
Density Conditions | densityConditions | - |
Chemical Structure | chemicalStructure | - |
Empirical Formula | empiricalFormula | - |
Molecular Weight | molecularWeight | - |
Chemical Name (CAS) | chemicalNameCAS | - |
Chemical Name (IUPAC) | chemicalNameIUPAC | - |
Other Names | otherNames | - |
INN/USAN | innUsan | - |
CAS Registry Number | casRegistryNumber | - |
Compendial Standard | compendialStandard | - |
COA/COC | certificateOfAnalysis | Boolean |
Properties Source Documents | propertiesLinks | Response is an array of encoded JSON objects in the format of Source Documents. |
References & Standards Source Documents |
| Response is an array of encoded JSON objects in the format of Source Documents. |
Version | DrugSubstanceVersions[ | Requires the usage of the Use |
Drug Product
Editable Name: DrugProduct
UI Attribute | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (DP) and the ID. |
Name | name | - |
CTD Filed Name |
| - |
Description | description | - |
Internal Part Number | internalPartNumber | - |
Source Documents | links | An array of encoded JSON objects in the format of Source Documents. |
Output | DrugSubstanceFlows[flow=Output].* | Drug Substance objects are limited to |
Attributes | DrugSubstanceToFQAs[*] | An array of encoded JSON objects representing links to FQAs and IQAs. |
Tags | tags | An array of encoded JSON objects. |
Drug Substance Type | drugSubstanceType | - |
Form | form | - |
Density | density | - |
Density Conditions | densityConditions | - |
Chemical Structure | chemicalStructure | - |
Empirical Formula | empiricalFormula | - |
Molecular Weight | molecularWeight | - |
Chemical Name (CAS) | chemicalNameCAS | - |
Chemical Name (IUPAC) | chemicalNameIUPAC | - |
Other Names | otherNames | - |
INN/USAN | innUsan | - |
CAS Registry Number | casRegistryNumber | - |
Compendial Standard | compendialStandard | - |
COA/COC | certificateOfAnalysis | Boolean |
Properties Source Documents | propertiesLinks | Response is an array of encoded JSON objects in the format of Source Documents. |
References & Standards Source Documents |
| Response is an array of encoded JSON objects in the format of Source Documents. |
Version | DrugProductVersions[ | Requires the usage of the Use |
Final Quality Attribute
Editable Name: FQA
UI Attributes | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (FQA) and the ID. |
Name | name | - |
Type | type | - |
Scope | scope | - |
Category | category | - |
Description | description | - |
Trace to TPP | TPPSections[*] | Array of JSON objects. |
Trace to General Attribute | GeneralAttributes[*] | Field depends on the Project’s risk assessment type. |
Risk Links | FPAToGeneralAttributeRisks | Field depends on the Project’s risk assessment type. |
Criticality (Raw) | riskInfo.Criticality.value | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality (%) | riskInfo.criticality.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality Risk Label | riskInfo.Criticality.riskLabel | - |
Criticality Score Label | riskInfo.Criticality.scoreLabel | - |
Recommended Actions | recommendedActions | - |
Scale Dependent | scaleDependent | - |
Scale Justification | scaleJustification | - |
Criticality Assessment Source Documents | riskLinks OR FPAToGeneralAttributeRisks[*].links | Response is an array of encoded JSON objects in the format of Source Documents. The If When one link is associated (via |
Data Space | dataSpace | - |
Measure | measure | - |
Measurement Units | measurementUnits | - |
Lower Limit | lowerLimit | Objects at the base come from the Primary Reporting Criteria. |
Target | target | Objects at the base come from the Primary Reporting Criteria. |
Upper Limit | upperLimit | Objects at the base come from the Primary Reporting Criteria. |
Control Methods | ControlMethods[*].name | Response is an array of objects containing summary Control Method details. |
Sampling Plan | samplingPlan | - |
Target Justification | targetJustification | - |
Acceptance Criteria Source Documents | acceptanceCriteriaLinks | An array of encoded JSON objects in the format of Source Documents. |
Capability Risk | capabilityRisk OR riskInfo.”Capability Risk”.riskScore | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
Process Risk (Raw) | riskinfo.”Process Risk”.value | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk (%) | riskInfo.”Process Risk”.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk Risk Lablel | riskInfo.”Process Risk”.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Estimated Sample Size | estimatedSampleSize | - |
Capability Justification | capabilityJustification | - |
Detectability Risk | detectabilityRisk || riskInfo.”Detectability Risk”.value riskInfo.”Capability Risk”.scoreLabel | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
RPN (Raw) | riskInfo.RPN.value | In Dynamics Tables, this field is combined with the Risk Label. |
RPN (%) | riskInfo.RPN.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
RPN Risk Lablel | riskInfo.RPN.normalizedValue | - |
Detectability Justification | riskInfo.RPN.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Control Strategy | controlStrategy | An array of Strings. |
CCP | CCP | - |
Control Strategy Justification | controlStrategyJustification | - |
Risk Control Source Documents | riskControlLinks | An array of encoded JSON objects in the format of Source Documents. |
References Source Documents | referencesLinks | An array of encoded JSON objects in the format of Source Documents. |
Version | FPAVersions[ | Requires the usage of the |
Final Performance Attribute
Editable Name: FPA
UI Attributes | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (FPA) and the ID. |
Name | name | - |
Type | type | - |
Scope | scope | - |
Category | category | - |
Description | description | - |
Trace to TPP | TPPSections[*] | Array of JSON objects. |
Trace to General Attribute | GeneralAttributes[*] | Field depends on the Project’s risk assessment type. |
Risk Links | FQAToGeneralAttributeRisks | Field depends on the Project’s risk assessment type. |
Criticality (Raw) | riskInfo.Criticality.value | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality (%) | riskInfo.criticality.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality Risk Label | riskInfo.Criticality.riskLabel | - |
Criticality Score Label | riskInfo.Criticality.scoreLabel | - |
Recommended Actions | recommendedActions | - |
Scale Dependent | scaleDependent | - |
Scale Justification | scaleJustification | - |
Criticality Assessment Source Documents | riskLinks OR FQAToGeneralAttributeRisks[*].links | Response is an array of encoded JSON objects in the format of Source Documents. The If When one link is associated (via |
Data Space | dataSpace | - |
Measure | measure | - |
Measurement Units | measurementUnits | - |
Lower Limit | lowerLimit | Objects at the base come from the Primary Reporting Criteria. |
Target | target | Objects at the base come from the Primary Reporting Criteria. |
Upper Limit | upperLimit | Objects at the base come from the Primary Reporting Criteria. |
Control Methods | ControlMethods[*].name | Response is an array of objects containing summary Control Method details. |
Sampling Plan | samplingPlan | - |
Target Justification | targetJustification | - |
Acceptance Criteria Source Documents | acceptanceCriteriaLinks | An array of encoded JSON objects in the format of Source Documents. |
Capability Risk | capabilityRisk OR riskInfo.”Capability Risk”.riskScore | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
Process Risk (Raw) | riskinfo.”Process Risk”.value | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk (%) | riskInfo.”Process Risk”.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk Risk Lablel | riskInfo.”Process Risk”.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Estimated Sample Size | estimatedSampleSize | - |
Capability Justification | capabilityJustification | - |
Detectability Risk | detectabilityRisk || riskInfo.”Detectability Risk”.value riskInfo.”Capability Risk”.scoreLabel | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
RPN (Raw) | riskInfo.RPN.value | In Dynamics Tables, this field is combined with the Risk Label. |
RPN (%) | riskInfo.RPN.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
RPN Risk Lablel | riskInfo.RPN.normalizedValue | - |
Detectability Justification | riskInfo.RPN.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Control Strategy | controlStrategy | An array of Strings. |
CCP | CCP | - |
Control Strategy Justification | controlStrategyJustification | - |
Risk Control Source Documents | riskControlLinks | An array of encoded JSON objects in the format of Source Documents. |
References Source Documents | referencesLinks | An array of encoded JSON objects in the format of Source Documents. |
Version | FQAVersions[ | Requires the usage of the |
Process Objects
Unit Operation
Editable Name: UnitOperation
UI Attribute | API Response | Comment |
---|---|---|
ID | id | The ID field in the UI is a concatenation of the TypeCode (UO) and the ID. |
Name | name | - |
Description | description | - |
Previous Unit | PreviousUnitId | ID is returned; name must be looked up. |
Supplier | Supplier.name | Supplier Object is in the return. |
input | input | This field is being depreciated in favor of new Input/Output Materials. |
output | output | This field is being depreciated in favor of new Input/Output Materials. |
Source Documents | links | An array of encoded JSON objects in the format of Source Documents. |
Tags | tags | An array of encoded JSON objects. |
Version | UnitOperationVersions[ | Requires the usage of the Use |
Step
Editable Name: Step
UI Attributes | API Response | Comment |
---|---|---|
ID | id | The ID field in the UI is a concatenation of the TypeCode (PP) and the ID. |
Name | name | - |
Description | description | - |
Unit Operation | UnitOperationId | ID is returned; the name must be looked up. |
Previous Step | PreviousStepId | ID is returned; the name must be looked up. |
Source Documents | links | Response is an array of encoded JSON objects in the format of Source Documents. |
Tags | tags | An array of encoded JSON objects. |
Version | StepVersions[ | Requires the usage of the Use |
Process Parameter
Editable Name: ProcessParaemter
UI Attributes | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (PP) and the ID. |
Name | name | - |
Material/Process Component | ProcessComponentId OR MaterialId
| A parameter can only belong to one. ID is returned; the name must be looked up. The |
Unit Operation | UnitOperation.name OR UnitOperationId | Other fields exist, including UnitOperationId and the |
Step | Step.name OR StepId | Other fields exist, including UnitOperationId and the |
Type | type | - |
Description | description | - |
Potential Failure Modes | potentialFailureModes | - |
Risk Links | ProcessParameterToIQAs[*].name ProcessParameterToIPAs[*].name ProcessParameterToFQAs[*].name ProcessParameterToFPAs[*].name | The user interface groups risk links together; however, the API response returns them as separate arrays according to their model. |
Criticality (Raw) | riskInfo.Criticality.value | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality (%) | riskInfo.criticality.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality Risk Label | riskInfo.Criticality.riskLabel | - |
Criticality Score Label | riskInfo.Criticality.scoreLabel | - |
Recommended Actions | recommendedActions | - |
Scale Dependent | scaleDependent | - |
Scale Justification | scaleJustification | - |
Criticality Assessment Source Documents | riskLinks OR ProcessParameterToIQAs[*].links ProcessParameterToIPAs[*].links ProcessParameterToFQAs[*].links ProcessParameterToFPAs[*].links | Response is an array of encoded JSON objects in the format of Source Documents. The If When one link is associated (via |
Data Space | dataSpace | - |
Measure | measure | - |
Measurement Units | measurementUnits | - |
Lower Limit | lowerLimit | Objects at the base come from the Primary Reporting Criteria. |
Target | target | Objects at the base come from the Primary Reporting Criteria. |
Upper Limit | upperLimit | Objects at the base come from the Primary Reporting Criteria. |
Control Methods | ControlMethods[*].name | Response is an array of objects containing summary Control Method details. |
Sampling Plan | samplingPlan | - |
Target Justification | targetJustification | - |
Lower Operating Limit | lowerOperatingLimit | - |
Upper Operating Limit | upperOperatingLimit | - |
Acceptance Criteria Source Documents | acceptanceCriteriaLinks | An array of encoded JSON objects in the format of Source Documents. |
Capability Risk | capabilityRisk OR riskInfo.”Capability Risk”.riskScore | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
Process Risk (Raw) | riskinfo.”Process Risk”.value | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk (%) | riskInfo.”Process Risk”.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk Risk Lablel | riskInfo.”Process Risk”.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Estimated Sample Size | estimatedSampleSize | - |
Capability Justification | capabilityJustification | - |
Detectability Risk | detectabilityRisk || riskInfo.”Detectability Risk”.value riskInfo.”Capability Risk”.scoreLabel | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
RPN (Raw) | riskInfo.RPN.value | In Dynamics Tables, this field is combined with the Risk Label. |
RPN (%) | riskInfo.RPN.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
RPN Risk Lablel | riskInfo.RPN.normalizedValue | - |
Detectability Justification | riskInfo.RPN.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Control Strategy | controlStrategy | An array of Strings. |
CCP | CCP | - |
Control Strategy Justification | controlStrategyJustification | - |
Risk Control Source Documents | riskControlLinks | An array of encoded JSON objects in the format of Source Documents. |
References Source Documents | referencesLinks | An array of encoded JSON objects in the format of Source Documents. |
Version | ProcessParameterVersions[ | Requires the usage of the Use |
Process Component
Editable Name: ProcessComponent
UI Attributes | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (PRC) and the ID. |
Name | name | - |
Unit Operations | UnitOperations[*].name | Process Component records can be shared. |
Steps | UnitOperations[*].name | - |
Type | type | - |
Function | function |
|
COA/COC | certificateOfAnalysis | Boolean |
Description | description | - |
Source Documents | links | Response is an array of encoded JSON objects in the format of Source Documents. |
Supplier | SupplierId Supplier.name | Supplier object included in response. |
Component Qualified | componentQualified | - |
Supplier Part Number | partNumber | - |
Internal Part Number | internalPartNumber | - |
Effective Date | effectiveDate | - |
Expiration Date | expirationDate | - |
Component Qualification Source Documents | componentQualificationLinks | Response is an array of encoded JSON objects in the format of Source Documents. |
Acceptance Testing | acceptanceTesting | - |
Qualification Status | qualificationStatus | - |
Unit ID | unitId | - |
Unit Qualification Source Documents | unitQualificationLinks | - |
Drug Product Contact | drugProductContact | - |
Contact Risk | contactRisk | - |
Contact Risk Justification | contactRiskJustification | - |
Cleaning Validation | cleaningValidation | - |
Sterilization Validation | sterilizationValidation | - |
Component Risk Source Documents | componentRiskLinks | Response is an array of encoded JSON objects in the format of Source Documents. |
References Source Documents | referencesLinks | Response is an array of encoded JSON objects in the format of Source Documents. |
Version | ProcessComponentVersions[ | Requires the usage of the Use |
Material
Editable Name: Material
UI Attributes | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (MA) and the ID. |
Name | name | - |
Function | function | - |
Use | use | - |
Category | category | SeeMaterials & Process Components | Material Categories for Material Categories. |
Description | description |
|
Input / Intermediate / Output | MaterialFlows[*].flow | MaterialFlows is an array of Objects representing the Material as it exists in different parts of the process.
SeeMaterials & Process Components | Input, Intermediate, and Output Materials for more details. |
Source Documents | links | Response is an array of encoded JSON objects in the format of Source Documents. |
Descriptive Unit (Absolute) | descriptiveUnitAbsolute | - |
Quantity per Batch (Absolute) | quantityAbsolute | - |
Quantity (Relative %) | quantityRelative | - |
Quantity per Dose (Absolute) | quantityPerDose | - |
Formulation Quantity Source Documents | formulationQuantityLinks | - |
Supplier | Supplier.name | Supplier object available on the root object. |
Material/Part Qualified | materialQualified | - |
GMP | gmp | - |
Supplier Part Number | partNumber | - |
Internal Part Number | internalPartNumber | - |
Effective Date | effectiveDate | - |
Expiration Date | expirationDate | - |
Qualification Source Documents | qualificationLinks | Response is an array of encoded JSON objects in the format of Source Documents. |
Regulatory Filing | regulatoryFiling | - |
Reference Number | referenceNumber | - |
Letter of Authorization | authorizationLetter | - |
Regulatory Source Documents | regulatoryLinks | Response is an array of encoded JSON objects in the format of Source Documents. |
Drug Substance Type | drugSubstanceType | - |
Form | form | - |
Density | density | - |
Density Conditions | densityConditions | - |
Chemical Structure | chemicalStructure | - |
Empirical Formula | empiricalFormula | - |
Molecular Weight | molecularWeight | - |
Chemical Name (CAS) | chemicalNameCAS | - |
Chemical Name (IUPAC) | chemicalNameIUPAC | - |
Other Names | otherNames | - |
INN/USAN | innUsan | - |
CAS Registry Number | casRegistryNumber | - |
Compendial Standard | compendialStandard | - |
COA/COC | certificateOfAnalysis | Boolean |
Properties Source Documents | propertiesLinks | Response is an array of encoded JSON objects in the format of Source Documents. |
References Source Documents | referencesLinks | Response is an array of encoded JSON objects in the format of Source Documents. |
Version | MaterialVersions[ | Requires the usage of the Use |
Material Attribute
Editable Name: MaterialAttribute
UI Attributes | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (MA) and the ID. |
Name | name | - |
Material/Process Component | ProcessComponentId OR MaterialId
| An Attribute can only belong to one. ID is returned; the name must be looked up. The |
Unit Operation | UnitOperation.name | Other fields exist, including UnitOperationId and the |
Step | StepId | Other fields exist, including UnitOperationId and the |
Type | type | - |
Description | description | - |
Potential Failure Modes | potentialFailureModes | - |
Risk Links | MaterialAttributeToFQAs[*].name MaterialAttributeToFPAs[*].name MaterialAttributeToIPAs[*].name MaterialAttributeToIQAs[*].name | The user interface groups risk links together; however, the API response returns them as separate arrays according to their model. |
Criticality (Raw) | riskInfo.Criticality.value | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality (%) | riskInfo.criticality.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality Risk Label | riskInfo.Criticality.riskLabel | - |
Criticality Score Label | riskInfo.Criticality.scoreLabel | - |
Recommended Actions | recommendedActions | - |
Scale Dependent | scaleDependent | - |
Scale Justification | scaleJustification | - |
Criticality Assessment Source Documents | riskLinks OR MaterialAttributeToFQAs[*].links MaterialAttributeToFPAs[*].links MaterialAttributeToIPAs[*].links MaterialAttributeToIQAs[*].links | Response is an array of encoded JSON objects in the format of Source Documents. The If When one link is associated (via |
Data Space | dataSpace | - |
Measure | measure | - |
Measurement Units | measurementUnits | - |
Lower Limit | lowerLimit | Objects at the base come from the Primary Reporting Criteria. |
Target | target | Objects at the base come from the Primary Reporting Criteria. |
Upper Limit | upperLimit | Objects at the base come from the Primary Reporting Criteria. |
Control Methods | ControlMethods[*].name | Response is an array of objects containing summary Control Method details. |
Sampling Plan | samplingPlan | - |
Target Justification | targetJustification | - |
Acceptance Criteria Source Documents | acceptanceCriteriaLinks | An array of encoded JSON objects in the format of Source Documents. |
Capability Risk | capabilityRisk OR riskInfo.”Capability Risk”.riskScore | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
Process Risk (Raw) | riskinfo.”Process Risk”.value | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk (%) | riskInfo.”Process Risk”.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk Risk Lablel | riskInfo.”Process Risk”.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Estimated Sample Size | estimatedSampleSize | - |
Capability Justification | capabilityJustification | - |
Detectability Risk | detectabilityRisk || riskInfo.”Detectability Risk”.value riskInfo.”Capability Risk”.scoreLabel | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
RPN (Raw) | riskInfo.RPN.value | In Dynamics Tables, this field is combined with the Risk Label. |
RPN (%) | riskInfo.RPN.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
RPN Risk Lablel | riskInfo.RPN.normalizedValue | - |
Detectability Justification | riskInfo.RPN.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Control Strategy | controlStrategy | An array of Strings. |
CCP | CCP | - |
Control Strategy Justification | controlStrategyJustification | - |
Risk Control Source Documents | riskControlLinks | An array of encoded JSON objects in the format of Source Documents. |
References Source Documents | referencesLinks | An array of encoded JSON objects in the format of Source Documents. |
Version | ProcessParameterVersions[ | Requires the usage of the Use |
Intermediate Quality Attribute
Editable Name: IQA
UI Attributes | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (IQA) and the ID. |
Name | name | - |
Material/Process Component | DrugProductId or DrugSubstanceId | An Attribute can only belong to one. ID is returned; the name must be looked up. |
Unit Operation | UnitOperation.name | Other fields exist, including UnitOperationId and the |
Step | StepId | Other fields exist, including UnitOperationId and the |
Type | type | - |
Description | description | - |
Risk Links | IQAToFQAs[*].name IQAToFPAs[*].name IQAToIPAs[*].name IQAToIQAs[*].name | The user interface groups risk links together; however, the API response returns them as separate arrays according to their model. |
Criticality (Raw) | riskInfo.Criticality.value | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality (%) | riskInfo.criticality.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality Risk Label | riskInfo.Criticality.riskLabel | - |
Criticality Score Label | riskInfo.Criticality.scoreLabel | - |
Recommended Actions | recommendedActions | - |
Scale Dependent | scaleDependent | - |
Scale Justification | scaleJustification | - |
Criticality Assessment Source Documents | riskLinks OR IQAToFQAs[*].links IQAToFPAs[*].links IQAToIPAs[*].links IQAToIQAs[*].links | Response is an array of encoded JSON objects in the format of Source Documents. The If When one link is associated (via |
Data Space | dataSpace | - |
Measure | measure | - |
Measurement Units | measurementUnits | - |
Lower Limit | lowerLimit | Objects at the base come from the Primary Reporting Criteria. |
Target | target | Objects at the base come from the Primary Reporting Criteria. |
Upper Limit | upperLimit | Objects at the base come from the Primary Reporting Criteria. |
Control Methods | ControlMethods[*].name | Response is an array of objects containing summary Control Method details. |
Sampling Plan | samplingPlan | - |
Target Justification | targetJustification | - |
Acceptance Criteria Source Documents | acceptanceCriteriaLinks | An array of encoded JSON objects in the format of Source Documents. |
Capability Risk | capabilityRisk OR riskInfo.”Capability Risk”.riskScore | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
Process Risk (Raw) | riskinfo.”Process Risk”.value | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk (%) | riskInfo.”Process Risk”.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk Risk Lablel | riskInfo.”Process Risk”.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Estimated Sample Size | estimatedSampleSize | - |
Capability Justification | capabilityJustification | - |
Detectability Risk | detectabilityRisk OR riskInfo.”Detectability Risk”.value riskInfo.”Capability Risk”.scoreLabel | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
RPN (Raw) | riskInfo.RPN.value | In Dynamics Tables, this field is combined with the Risk Label. |
RPN (%) | riskInfo.RPN.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
RPN Risk Lablel | riskInfo.RPN.normalizedValue | - |
Detectability Justification | riskInfo.RPN.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Control Strategy | controlStrategy | An array of Strings. |
CCP | CCP | - |
Control Strategy Justification | controlStrategyJustification | - |
Risk Control Source Documents | riskControlLinks | An array of encoded JSON objects in the format of Source Documents. |
References Source Documents | referencesLinks | An array of encoded JSON objects in the format of Source Documents. |
Version | IQAVersions[ | Requires the usage of the |
Intermediate Performance Attribute
Editable Name: IPA
UI Attributes | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (IPA) and the ID. |
Name | name | - |
Material/Process Component | DrugProductId or DrugSubstanceId | An Attribute can only belong to one. ID is returned; the name must be looked up. |
Unit Operation | UnitOperation.name | Other fields exist, including UnitOperationId and the |
Step | StepId | Other fields exist, including UnitOperationId and the |
Type | type | - |
Description | description | - |
Risk Links | IPAToFQAs[*].name IPAToFPAs[*].name IPAToIPAs[*].name IPAToIQAs[*].name | The user interface groups risk links together; however, the API response returns them as separate arrays according to their model. |
Criticality (Raw) | riskInfo.Criticality.value | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality (%) | riskInfo.criticality.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Criticality Risk Label | riskInfo.Criticality.riskLabel | - |
Criticality Score Label | riskInfo.Criticality.scoreLabel | - |
Recommended Actions | recommendedActions | - |
Scale Dependent | scaleDependent | - |
Scale Justification | scaleJustification | - |
Criticality Assessment Source Documents | riskLinks OR IPAToFQAs[*].links IPAToFPAs[*].links IPAToIPAs[*].links IPAToIQAs[*].links | Response is an array of encoded JSON objects in the format of Source Documents. The If When one link is associated (via |
Data Space | dataSpace | - |
Measure | measure | - |
Measurement Units | measurementUnits | - |
Lower Limit | lowerLimit | Objects at the base come from the Primary Reporting Criteria. |
Target | target | Objects at the base come from the Primary Reporting Criteria. |
Upper Limit | upperLimit | Objects at the base come from the Primary Reporting Criteria. |
Control Methods | ControlMethods[*].name | Response is an array of objects containing summary Control Method details. |
Sampling Plan | samplingPlan | - |
Target Justification | targetJustification | - |
Acceptance Criteria Source Documents | acceptanceCriteriaLinks | An array of encoded JSON objects in the format of Source Documents. |
Capability Risk | capabilityRisk OR riskInfo.”Capability Risk”.riskScore | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
Process Risk (Raw) | riskinfo.”Process Risk”.value | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk (%) | riskInfo.”Process Risk”.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
Process Risk Risk Lablel | riskInfo.”Process Risk”.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Estimated Sample Size | estimatedSampleSize | - |
Capability Justification | capabilityJustification | - |
Detectability Risk | detectabilityRisk || riskInfo.”Detectability Risk”.value riskInfo.”Capability Risk”.scoreLabel | In the UI, capability risk is contacted with the value and the label. The riskInfo is the preferred method for accessing. |
RPN (Raw) | riskInfo.RPN.value | In Dynamics Tables, this field is combined with the Risk Label. |
RPN (%) | riskInfo.RPN.normalizedValue | In Dynamics Tables, this field is combined with the Risk Label. |
RPN Risk Lablel | riskInfo.RPN.normalizedValue | - |
Detectability Justification | riskInfo.RPN.riskLabel | This field is not shown in the Record UI. It is visible in Dynamic Tables and other reporting interfaces. |
Control Strategy | controlStrategy | An array of Strings. |
CCP | CCP | - |
Control Strategy Justification | controlStrategyJustification | - |
Risk Control Source Documents | riskControlLinks | An array of encoded JSON objects in the format of Source Documents. |
References Source Documents | referencesLinks | An array of encoded JSON objects in the format of Source Documents. |
Version | IPAVersions[ | Requires the usage of the Use |
Other Objects
Control Methods
Editable Name: ControlMethod
UI Attributes | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (CM) and the ID. |
Name | name | - |
Type | type | - |
Category | category | - |
Compendial Standard | compendialStandard | - |
Description | description | - |
Equipment | equipment | - |
Control Method Links | controlMethodLinks | An array of encoded JSON objects in the format of Source Documents. |
Supplier | SupplierId Supplier.name | Supplier object included in the response. |
Status | status |
|
Stability Indicating | stabilityIndicating |
|
Method Development Source Documents | developmentLinks | An array of encoded JSON objects in the format of Source Documents. |
References Source Documents | referencesLinks | An array of encoded JSON objects in the format of Source Documents. |
Version | ControlMethodVersions[ | Requires the usage of the Use |
Documents
Editable Name: Document
UI Attributes | API Response | Comment |
---|---|---|
ID | typeCode + “ -” + id | The ID field in the UI is a concatenation of the TypeCode (DOC) and the ID. |
Name | name | - |
Custom ID | customID | - |
Project | project.name | JSON Object |
Type | type | - |
Controlled | controlled | - |
Category | category | - |
Effective Date | effectiveDate | - |
Site | site | - |
Purpose | purpose | - |
Scope | scope | - |
Author(s) | author | - |
SME(s) | sme | - |
Final Document | uploadDocumentLinks | JSON Object of Source Documents |
Source Document | If documentContent Else: originalDocumentLinks | The |
Regulatory Document | regulatoryDocument | - |
eCTD Section | ectdSection | - |
DHF Section | dhfSection | - |
DMR Section | dmrSection | - |
510(k) Section | k510Section | - |
PMA Section | pmaSection | - |
References and Standards | referencesLinks | JSON Object of Source Documents |
Data: Batch
Editable Name: Batch
UI Attributes | API Response | Comment |
---|---|---|
ID | customID | The ID referenced in the user interface comes from the |
Type | batchType | Array of possible types |
Process | ProcessId | ID is returned; the name must be looked up. |
Supplier | SupplierId | ID is returned; the name must be looked up. |
Start Date | startDate | - |
Manufacture Date | manufactureDate | - |
Release Date | releaseDate | - |
Expiration Date | expirationDate | - |
Site | site | - |
Scale | scale | - |
Purpose | purpose | - |
Release / Manufacturing | attributes | List of Attribute objects. |
Additional Query Parameter Details
The following table is supplemental to our API documentation found in your instance of QbDVision.
End-point | Description | Filter | Response |
---|---|---|---|
/editables/${model}/list/${projectId} | Returns basic information for records filtered by model and projectId. Basic fields:
Version retrieved:
model:
| blank | Returns Approved if exists, but otherwise draft Includes field named |
onlyApproved=true | Returns only objects that are approved and don’t have a new draft | ||
| Includes also the archived records | ||
| includes a field (array) named | ||
| includes a field (array) named | ||
sortBy=field,direction | field = any field from the record (name, description) direction = asc or desc | ||
/editables/${model}/${recordId} | Return full information about a record. Version retrieved:
| blank | Returns Approved if exists, but otherwise draft |
approved=false | Returns last version from the record (regardless if it is approved or draft) | ||
approved =true | Returns last approved version | ||
includeHistory=true | Includes a field (Array) ${model}Versions with all the versions of the record | ||
/editables/multiple/list/${projectId} | Get multiple records by recordId and projectId Request method: PUT Sample Request Payload: Response is always compressed
Returns the latest version of the record (regardless if it was approved or not) | blank | Returns the latest version of the record (regardless if it was approved or not) |
returnLatestApprovedOrDraftVersionsOnly=true | Version retrieved:
| ||
includeHistory=true | Includes all the versions for the retrieved record | ||
/processExplorer/${projectId} | Get all process records for a projectId Only basic information for record is retrieved (id, name, currentState) Version retrieved:
| blank | Returns compressed result |
shouldCompress=false | Returns uncompressed result | ||
| Return the latest approved version of records. Records without any approved version will not be returned. | ||
| Returns records from the specified process | ||
outputStructure=tree|map | Result format in Tree or Map format. Default: map | ||
| For XML data you need to use outputStructure=tree and standard=ISA-95 Default: json |