QbDVision API Objects

QbDVision API Objects

Table of Contents

Product Objects

Drug Substance

Editable Name: DrugSubstance

UI Attribute

API Response

Comment

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 flow of output and can only have one output.

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

referencesLinks

Response is an array of encoded JSON objects in the format of Source Documents.

Version

DrugSubstanceVersions[<version ID>].majorVersion + “.” + DrugSubstanceVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Use LastVersionId or LastApprovedVersionId to access the array.

Drug Product

Editable Name: DrugProduct

UI Attribute

API Response

Comment

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 flow of output and can only have one output.

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

referencesLinks

Response is an array of encoded JSON objects in the format of Source Documents.

Version

DrugProductVersions[<version ID>].majorVersion + “.” + DrugProductVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Use LastVersionId or LastApprovedVersionId to access the array.

Final Quality Attribute

Editable Name: FQA

UI Attributes

API Response

Comment

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 riskLinks object is used when the AppliesTo field isn’t associated with relationships (e.g., Attribute to IQA).

If AppliesTo references a relationship, the response object will be included in the relationship array's links object.

When one link is associated (via AppliesTo) with different model types, then the link is returned in both objects.

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
riskInfo.”Capability Risk”.scoreLabel

In the UI, capability risk is contacted with the value and the label.

The capabilityRisk attribute returns the raw value and sits at the root of the response object.

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 detectabilityRisk attribute returns the raw value and sits at the root of the response object.

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[<version ID>].majorVersion + “.” + FPAVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Final Performance Attribute

Editable Name: FPA

UI Attributes

API Response

Comment

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 riskLinks object is used when the AppliesTo field isn’t associated with relationships (e.g., Attribute to IQA).

If AppliesTo references a relationship, the response object will be included in the relationship array's links object.

When one link is associated (via AppliesTo) with different model types, then the link is returned in both objects.

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
riskInfo.”Capability Risk”.scoreLabel

In the UI, capability risk is contacted with the value and the label.

The capabilityRisk attribute returns the raw value and sits at the root of the response object.

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 detectabilityRisk attribute returns the raw value and sits at the root of the response object.

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[<version ID>].majorVersion + “.” + FQAVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Process Objects

Unit Operation

Editable Name: UnitOperation

UI Attribute

API Response

Comment

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[<version ID>].majorVersion + “.” + UnitOperationVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Use LastVersionId or LastApprovedVersionId to access the array.

Step

Editable Name: Step

UI Attributes

API Response

Comment

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[<version ID>].majorVersion + “.” + StepVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Use LastVersionId or LastApprovedVersionId to access the array.

 

Process Parameter

Editable Name: ProcessParaemter

UI Attributes

API Response

Comment

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 parents array can also be used for lookup.

Unit Operation

UnitOperation.name OR

UnitOperationId

Other fields exist, including UnitOperationId and the parents array.

Step

Step.name OR

StepId

Other fields exist, including UnitOperationId and the parents array.

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 riskLinks object is used when the AppliesTo field isn’t associated with relationships (e.g., Process Parameter to IQA).

If AppliesTo references a relationship, the response object will be included in the relationship array's links object.

When one link is associated (via AppliesTo) with different model types, then the link is returned in both objects.

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
riskInfo.”Capability Risk”.scoreLabel

In the UI, capability risk is contacted with the value and the label.

The capabilityRisk attribute returns the raw value and sits at the root of the response object.

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 detectabilityRisk attribute returns the raw value and sits at the root of the response object.

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[<version ID>].majorVersion + “.” + ProcessParameterVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Use LastVersionId or LastApprovedVersionId to access the array.

Process Component

Editable Name: ProcessComponent

UI Attributes

API Response

Comment

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[<version ID>].majorVersion + “.” + ProcessComponentVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Use LastVersionId or LastApprovedVersionId to access the array.

Material

Editable Name: Material

UI Attributes

API Response

Comment

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[<version ID>].majorVersion + “.” + MaterialVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Use LastVersionId or LastApprovedVersionId to access the array.

Material Attribute

Editable Name: MaterialAttribute

UI Attributes

API Response

Comment

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 parents array can also be used for lookup.

Unit Operation

UnitOperation.name

Other fields exist, including UnitOperationId and the parents array.

Step

StepId

Other fields exist, including UnitOperationId and the parents array.

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 riskLinks object is used when the AppliesTo field isn’t associated with relationships (e.g., Attribute to IQA).

If AppliesTo references a relationship, the response object will be included in the relationship array's links object.

When one link is associated (via AppliesTo) with different model types, then the link is returned in both objects.

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
riskInfo.”Capability Risk”.scoreLabel

In the UI, capability risk is contacted with the value and the label.

The capabilityRisk attribute returns the raw value and sits at the root of the response object.

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 detectabilityRisk attribute returns the raw value and sits at the root of the response object.

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[<version ID>].majorVersion + “.” + ProcessParameterVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Use LastVersionId or LastApprovedVersionId to access the array.

Intermediate Quality Attribute

Editable Name: IQA

UI Attributes

API Response

Comment

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 parents array.

Step

StepId

Other fields exist, including UnitOperationId and the parents array.

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 riskLinks object is used when the AppliesTo field isn’t associated with relationships (e.g., Attribute to IQA).

If AppliesTo references a relationship, the response object will be included in the relationship array's links object.

When one link is associated (via AppliesTo) with different model types, then the link is returned in both objects.

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
riskInfo.”Capability Risk”.scoreLabel

In the UI, capability risk is contacted with the value and the label.

The capabilityRisk attribute returns the raw value and sits at the root of the response object.

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 detectabilityRisk attribute returns the raw value and sits at the root of the response object.

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[<version ID>].majorVersion + “.” + IQAVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Intermediate Performance Attribute

Editable Name: IPA

UI Attributes

API Response

Comment

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 parents array.

Step

StepId

Other fields exist, including UnitOperationId and the parents array.

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 riskLinks object is used when the AppliesTo field isn’t associated with relationships (e.g., Attribute to IQA).

If AppliesTo references a relationship, the response object will be included in the relationship array's links object.

When one link is associated (via AppliesTo) with different model types, then the link is returned in both objects.

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
riskInfo.”Capability Risk”.scoreLabel

In the UI, capability risk is contacted with the value and the label.

The capabilityRisk attribute returns the raw value and sits at the root of the response object.

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 detectabilityRisk attribute returns the raw value and sits at the root of the response object.

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[<version ID>].majorVersion + “.” + IPAVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Use LastVersionId or LastApprovedVersionId to access the array.

Other Objects

Control Methods

Editable Name: ControlMethod

UI Attributes

API Response

Comment

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[<version ID>].majorVersion + “.” + ControlMethodVersions[<version ID>].minorVersion

Requires the usage of the includeHistory query parameter.

Use LastVersionId or LastApprovedVersionId to access the array.

Documents

Editable Name: Document

UI Attributes

API Response

Comment

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 isQbdSrcDoc=true

documentContent

Else: originalDocumentLinks

The documentContent object is the representation of a QbDVision document (Doc Builder).

Regulatory Document

regulatoryDocument

-

eCTD Section

ectdSection

-

DHF Section

dhfSection

-

DMR Section

dmrSection

-

510(k) Section

k510Section

-

PMA Section

pmaSection

-

References and Standards
Source Documents

referencesLinks

JSON Object of Source Documents

Data: Batch

Editable Name: Batch

UI Attributes

API Response

Comment

UI Attributes

API Response

Comment

ID

customID

The ID referenced in the user interface comes from the customID field. However, these objects also maintain a QbDVision ID, which is used to query and comes back in the response object as id.

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

End-point

Description

Filter

Response

/editables/${model}/list/${projectId}

Returns basic information for records filtered by model and projectId.

Basic fields:

  • id

  • name

  • currentState

  • modelName

  • majorVersion

  • minorVersion

Version retrieved:

  • Latest approved version

  • Draft if there was not a previously approved version

model:

  • FQA

  • FPA

  • ProcessParameter

  • MaterialAttribute

  • UnitOperation

  • Step

  • IQA

  • IPA

blank

Returns Approved if exists, but otherwise draft

Includes field named LastVersionthat contains information about the last version of the record.

onlyApproved=true

Returns only objects that are approved and don’t have a new draft

showRemoved=true

Includes also the archived records

includeAllVersions=true

includes a field (array) named allVersionsWithDetails. This field contains all the versions, and each version includes all the fields.

includeAllApprovedVersions=true

includes a field (array) named approvedVersionsWithDetails. This field contains the approved versions and each version includes all the fields.

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:

  • Latest approved version

  • Draft if there was not a previously approved version

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:
{"requirementIds":["PR-2","UO-1","UO-2","UO-3","PP-1","PP-2","PP-3"]}

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:

  • Latest approved version

  • Draft if there is not a previously approved version

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:

  • Latest approved version

  • Draft if there was not a previously approved version

blank

Returns compressed result

shouldCompress=false

Returns uncompressed result

approvedOnly=true

Return the latest approved version of records. Records without any approved version will not be returned.

processId=${processId}

Returns records from the specified process

outputStructure=tree|map

Result format in Tree or Map format. Default: map

outputFormat=XML|JSON

For XML data you need to use outputStructure=tree and standard=ISA-95

Default: json

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