@nyrra/prismantix-oac-pharma 0.0.1

package/dist/lib/prismantix/valueTypes.mjs

@@ -0,0 +1,586 @@
+import { defineValueType } from "@nyrra/maker";
+export const EpochMillisValueType = defineValueType({
+    apiName: "EpochMillis",
+    description: "Unix epoch timestamp in milliseconds.",
+    displayName: "Epoch Milliseconds",
+    exampleValues: [1707436800000],
+    type: {
+        type: "integer",
+    },
+});
+export const IsoTimestampStringValueType = defineValueType({
+    apiName: "IsoTimestampString",
+    description: "ISO 8601 timestamp string.",
+    displayName: "ISO Timestamp String",
+    exampleValues: ["2025-03-15T00:00:00Z"],
+    type: {
+        type: "string",
+    },
+});
+export const SiteRegionValueType = defineValueType({
+    apiName: "SiteRegion",
+    description: "Geographic region for global pharmaceutical presence",
+    displayName: "Region",
+    exampleValues: ["North America", "Europe", "Asia Pacific"],
+    type: {
+        type: "enum",
+        values: [
+            "North America",
+            "Europe",
+            "Asia Pacific",
+            "Latin America",
+            "Middle East & Africa",
+        ],
+    },
+});
+export const SiteSiteTypeValueType = defineValueType({
+    apiName: "SiteSiteType",
+    description: "Type of pharmaceutical facility operations",
+    displayName: "Site Type",
+    exampleValues: ["Manufacturing", "R&D"],
+    type: {
+        type: "enum",
+        values: ["Manufacturing", "Packaging", "R&D", "Distribution"],
+    },
+});
+export const SiteStatusValueType = defineValueType({
+    apiName: "SiteStatus",
+    description: "Operational status of the facility",
+    displayName: "Status",
+    exampleValues: ["Active"],
+    type: {
+        type: "enum",
+        values: ["Active", "Inactive"],
+    },
+});
+export const SiteValidationStatusValueType = defineValueType({
+    apiName: "SiteValidationStatus",
+    description: "Regulatory validation status",
+    displayName: "Validation Status",
+    exampleValues: ["Validated", "In Progress"],
+    type: {
+        type: "enum",
+        values: ["Validated", "In Progress", "Pending"],
+    },
+});
+export const ProductDevelopmentStageValueType = defineValueType({
+    apiName: "ProductDevelopmentStage",
+    description: "Current development/lifecycle stage",
+    displayName: "Development Stage",
+    exampleValues: ["Commercial"],
+    type: {
+        type: "enum",
+        values: ["Commercial", "Phase III", "Phase II", "Phase I", "Preclinical"],
+    },
+});
+export const ProductDosageFormValueType = defineValueType({
+    apiName: "ProductDosageForm",
+    description: "Pharmaceutical dosage form that matches the product type",
+    displayName: "Dosage Form",
+    exampleValues: ["Pre-filled Pen", "Tablet"],
+    type: {
+        type: "enum",
+        values: [
+            "Tablet",
+            "Capsule",
+            "Injection",
+            "Pre-filled Pen",
+            "Vial",
+            "Inhaler",
+            "Cream",
+            "Ointment",
+            "Solution",
+            "Suspension",
+            "Patch",
+            "Suppository",
+        ],
+    },
+});
+export const ProductProductTypeValueType = defineValueType({
+    apiName: "ProductProductType",
+    description: "Product classification type",
+    displayName: "Product Type",
+    exampleValues: ["Branded"],
+    type: {
+        type: "enum",
+        values: ["Branded", "Generic", "Biosimilar", "OTC"],
+    },
+});
+export const ProductRegulatoryStatusValueType = defineValueType({
+    apiName: "ProductRegulatoryStatus",
+    description: "Current regulatory status",
+    displayName: "Regulatory Status",
+    exampleValues: ["Active"],
+    type: {
+        type: "enum",
+        values: [
+            "Active",
+            "Discontinued",
+            "Under Review",
+            "Pending Approval",
+            "Withdrawn",
+        ],
+    },
+});
+export const ProductTherapeuticAreaValueType = defineValueType({
+    apiName: "ProductTherapeuticArea",
+    description: "Primary therapeutic area that matches the product's indication",
+    displayName: "Therapeutic Area",
+    exampleValues: ["Diabetes Care", "Oncology"],
+    type: {
+        type: "enum",
+        values: [
+            "Diabetes Care",
+            "Oncology",
+            "Immunology",
+            "Neuroscience",
+            "Cardiovascular",
+            "Respiratory",
+            "Anti-infectives",
+            "Gastroenterology",
+            "Dermatology",
+            "Rare Diseases",
+        ],
+    },
+});
+export const EquipmentStatusValueType = defineValueType({
+    apiName: "EquipmentStatus",
+    description: "Operational status",
+    displayName: "Status",
+    exampleValues: ["Active", "UnderMaintenance", "CalDue"],
+    type: {
+        type: "enum",
+        values: ["Active", "Inactive", "UnderMaintenance", "CalDue"],
+    },
+});
+export const SupplierCategoryValueType = defineValueType({
+    apiName: "SupplierCategory",
+    description: "Criticality classification based on impact to pharmaceutical operations",
+    displayName: "Category",
+    exampleValues: ["Critical", "Major"],
+    type: {
+        type: "enum",
+        values: ["Critical", "Major", "Minor"],
+    },
+});
+export const SupplierCertificationStatusValueType = defineValueType({
+    apiName: "SupplierCertificationStatus",
+    description: "Current pharmaceutical quality certification status",
+    displayName: "Certification Status",
+    exampleValues: ["Certified", "Pending"],
+    type: {
+        type: "enum",
+        values: ["Certified", "Pending", "Expired", "Suspended"],
+    },
+});
+export const SupplierStatusValueType = defineValueType({
+    apiName: "SupplierStatus",
+    description: "Current business relationship status",
+    displayName: "Status",
+    exampleValues: ["Active"],
+    type: {
+        type: "enum",
+        values: ["Active", "Inactive"],
+    },
+});
+export const SupplierSupplierTypeValueType = defineValueType({
+    apiName: "SupplierSupplierType",
+    description: "Primary type of materials or services provided to pharmaceutical manufacturers",
+    displayName: "Supplier Type",
+    exampleValues: ["Services", "API", "Excipient", "Packaging", "Equipment"],
+    type: {
+        type: "enum",
+        values: ["API", "Excipient", "Packaging", "Equipment", "Services"],
+    },
+});
+export const BatchBatchSizeUnitValueType = defineValueType({
+    apiName: "BatchBatchSizeUnit",
+    description: "Unit of measurement for batch size",
+    displayName: "Batch Size Unit",
+    exampleValues: ["tablets", "kg", "vials"],
+    type: {
+        type: "enum",
+        values: ["tablets", "capsules", "vials", "kg", "L", "units"],
+    },
+});
+export const BatchReleaseStatusValueType = defineValueType({
+    apiName: "BatchReleaseStatus",
+    description: "Quality release status for the batch",
+    displayName: "Release Status",
+    exampleValues: ["Approved", "On Hold", "Pending"],
+    type: {
+        type: "enum",
+        values: ["Pending", "Approved", "Rejected", "On Hold"],
+    },
+});
+export const BatchStatusValueType = defineValueType({
+    apiName: "BatchStatus",
+    description: "Current batch status in quality control workflow",
+    displayName: "Status",
+    exampleValues: ["Released", "Quarantined", "In Testing"],
+    type: {
+        type: "enum",
+        values: [
+            "In Process",
+            "In Testing",
+            "Quarantined",
+            "Released",
+            "Rejected",
+            "Expired",
+        ],
+    },
+});
+export const DeviationCategoryValueType = defineValueType({
+    apiName: "DeviationCategory",
+    description: "Classification category of the deviation",
+    displayName: "Category",
+    exampleValues: ["Environmental", "Process", "Equipment"],
+    type: {
+        type: "enum",
+        values: [
+            "Process",
+            "Equipment",
+            "Documentation",
+            "Material",
+            "Environmental",
+            "Other",
+        ],
+    },
+});
+export const DeviationSeverityValueType = defineValueType({
+    apiName: "DeviationSeverity",
+    description: "Severity level based on potential impact to product quality and patient safety",
+    displayName: "Severity",
+    exampleValues: ["Major", "Critical"],
+    type: {
+        type: "enum",
+        values: ["Critical", "Major", "Minor"],
+    },
+});
+export const DeviationStatusValueType = defineValueType({
+    apiName: "DeviationStatus",
+    description: "Current status in the deviation management workflow",
+    displayName: "Status",
+    exampleValues: ["Under Investigation", "CAPA Required", "Closed"],
+    type: {
+        type: "enum",
+        values: ["Open", "Under Investigation", "CAPA Required", "Closed"],
+    },
+});
+export const ComplaintComplaintTypeValueType = defineValueType({
+    apiName: "ComplaintComplaintType",
+    description: "Primary classification of the complaint type",
+    displayName: "Complaint Type",
+    exampleValues: ["Product Quality", "Adverse Event", "Packaging", "Efficacy"],
+    type: {
+        type: "enum",
+        values: [
+            "Product Quality",
+            "Adverse Event",
+            "Packaging",
+            "Labeling",
+            "Efficacy",
+        ],
+    },
+});
+export const ComplaintReporterTypeValueType = defineValueType({
+    apiName: "ComplaintReporterType",
+    description: "Type of person or entity reporting the complaint",
+    displayName: "Reporter Type",
+    exampleValues: ["Patient", "Healthcare Professional", "Distributor"],
+    type: {
+        type: "enum",
+        values: ["Healthcare Professional", "Patient", "Distributor", "Regulatory"],
+    },
+});
+export const ComplaintSeverityValueType = defineValueType({
+    apiName: "ComplaintSeverity",
+    description: "Severity assessment based on potential patient impact",
+    displayName: "Severity",
+    exampleValues: ["Minor", "Major", "Critical"],
+    type: {
+        type: "enum",
+        values: ["Critical", "Major", "Minor"],
+    },
+});
+export const ComplaintStatusValueType = defineValueType({
+    apiName: "ComplaintStatus",
+    description: "Current status in complaint management workflow",
+    displayName: "Status",
+    exampleValues: ["Closed", "Investigation", "Under Review"],
+    type: {
+        type: "enum",
+        values: ["New", "Under Review", "Investigation", "Closed"],
+    },
+});
+export const InvestigationPriorityValueType = defineValueType({
+    apiName: "InvestigationPriority",
+    description: "Investigation priority based on potential impact and urgency",
+    displayName: "Priority",
+    exampleValues: ["High", "Medium"],
+    type: {
+        type: "enum",
+        values: ["High", "Medium", "Low"],
+    },
+});
+export const InvestigationStatusValueType = defineValueType({
+    apiName: "InvestigationStatus",
+    description: "Current status in investigation lifecycle",
+    displayName: "Status",
+    exampleValues: ["In Progress", "Completed", "Closed"],
+    type: {
+        type: "enum",
+        values: ["Planned", "In Progress", "Completed", "Closed"],
+    },
+});
+export const InvestigationTypeValueType = defineValueType({
+    apiName: "InvestigationType",
+    description: "Type of event or finding that triggered the investigation",
+    displayName: "Type",
+    exampleValues: ["Deviation", "OOS", "Complaint"],
+    type: {
+        type: "enum",
+        values: ["Deviation", "Complaint", "OOS", "Audit Finding"],
+    },
+});
+export const CapaCategoryValueType = defineValueType({
+    apiName: "CapaCategory",
+    description: "Primary category of the CAPA actions",
+    displayName: "Category",
+    exampleValues: ["System", "Process", "Equipment"],
+    type: {
+        type: "enum",
+        values: ["Process", "System", "Documentation", "Training", "Equipment"],
+    },
+});
+export const CapaPriorityValueType = defineValueType({
+    apiName: "CapaPriority",
+    description: "Priority level based on risk assessment and business impact",
+    displayName: "Priority",
+    exampleValues: ["High", "Critical", "Medium"],
+    type: {
+        type: "enum",
+        values: ["Critical", "High", "Medium", "Low"],
+    },
+});
+export const CapaSourceTypeValueType = defineValueType({
+    apiName: "CapaSourceType",
+    description: "Type of quality event that triggered the CAPA",
+    displayName: "Source Type",
+    exampleValues: ["Deviation", "Complaint"],
+    type: {
+        type: "enum",
+        values: ["Deviation", "Complaint", "Audit", "Management Review"],
+    },
+});
+export const CapaStatusValueType = defineValueType({
+    apiName: "CapaStatus",
+    description: "Current status in CAPA lifecycle management",
+    displayName: "Status",
+    exampleValues: ["In Progress", "Verification", "Closed", "Open"],
+    type: {
+        type: "enum",
+        values: ["Draft", "Open", "In Progress", "Verification", "Closed"],
+    },
+});
+export const CapaTypeValueType = defineValueType({
+    apiName: "CapaType",
+    description: 'Classification of action type (most should be "Both" for comprehensive approach)',
+    displayName: "Type",
+    exampleValues: ["Both"],
+    type: {
+        type: "enum",
+        values: ["Corrective", "Preventive", "Both"],
+    },
+});
+export const ActionItemStatusValueType = defineValueType({
+    apiName: "ActionItemStatus",
+    description: "Current status of the action item (use 'Late' for past due items)",
+    displayName: "Status",
+    exampleValues: ["Open", "InProgress"],
+    type: {
+        type: "enum",
+        values: ["Open", "InProgress", "Done", "Late"],
+    },
+});
+export const ChangeControlChangeCategoryValueType = defineValueType({
+    apiName: "ChangeControlChangeCategory",
+    description: "Primary category of the change",
+    displayName: "Change Category",
+    exampleValues: ["Document", "Equipment"],
+    type: {
+        type: "enum",
+        values: [
+            "Document",
+            "Process",
+            "Equipment",
+            "Supplier",
+            "ComputerSystem",
+            "Packaging",
+            "Other",
+        ],
+    },
+});
+export const ChangeControlGxPImpactValueType = defineValueType({
+    apiName: "ChangeControlGxPImpact",
+    description: "Whether this is GxP impacting",
+    displayName: "GxP Impact",
+    exampleValues: ["GxP"],
+    type: {
+        type: "enum",
+        values: ["GxP", "Non-GxP"],
+    },
+});
+export const ChangeControlRiskAfterValueType = defineValueType({
+    apiName: "ChangeControlRiskAfter",
+    description: "Risk After for change control.",
+    displayName: "Risk After",
+    type: {
+        type: "enum",
+        values: ["Low", "Medium", "High"],
+    },
+});
+export const ChangeControlRiskBeforeValueType = defineValueType({
+    apiName: "ChangeControlRiskBefore",
+    description: "Risk level prior to change",
+    displayName: "Risk Before",
+    exampleValues: ["Medium", "High"],
+    type: {
+        type: "enum",
+        values: ["Low", "Medium", "High"],
+    },
+});
+export const ChangeControlStatusValueType = defineValueType({
+    apiName: "ChangeControlStatus",
+    description: "Current lifecycle status",
+    displayName: "Status",
+    exampleValues: ["ImpactAssessment", "ApprovalPending"],
+    type: {
+        type: "enum",
+        values: [
+            "Draft",
+            "ImpactAssessment",
+            "ApprovalPending",
+            "Approved",
+            "Implementation",
+            "Verification",
+            "Closed",
+            "Rejected",
+        ],
+    },
+});
+export const ChangeControlImpactImpactAreaValueType = defineValueType({
+    apiName: "ChangeControlImpactImpactArea",
+    description: "Area impacted by the change",
+    displayName: "Impact Area",
+    exampleValues: ["Equipment", "Document"],
+    type: {
+        type: "enum",
+        values: [
+            "Product",
+            "Process",
+            "Equipment",
+            "Document",
+            "ComputerSystem",
+            "Supplier",
+            "Training",
+            "Validation",
+            "Other",
+        ],
+    },
+});
+export const ChangeControlImpactImpactSeverityValueType = defineValueType({
+    apiName: "ChangeControlImpactImpactSeverity",
+    description: "Severity of the impact",
+    displayName: "Impact Severity",
+    exampleValues: ["High", "Medium"],
+    type: {
+        type: "enum",
+        values: ["Low", "Medium", "High"],
+    },
+});
+export const ChangeControlApprovalDecisionValueType = defineValueType({
+    apiName: "ChangeControlApprovalDecision",
+    description: "Approval decision",
+    displayName: "Decision",
+    exampleValues: ["Pending", "Approved", "Rejected"],
+    type: {
+        type: "enum",
+        values: ["Pending", "Approved", "Rejected"],
+    },
+});
+export const ChangeControlApprovalRoleValueType = defineValueType({
+    apiName: "ChangeControlApprovalRole",
+    description: "Approver role",
+    displayName: "Role",
+    exampleValues: ["QA", "Validation", "Regulatory"],
+    type: {
+        type: "enum",
+        values: [
+            "QA",
+            "Manufacturing",
+            "IT",
+            "Validation",
+            "SupplyChain",
+            "Regulatory",
+            "Other",
+        ],
+    },
+});
+export const ChangeControlEffectivenessStatusValueType = defineValueType({
+    apiName: "ChangeControlEffectivenessStatus",
+    description: "Current status of effectiveness check",
+    displayName: "Status",
+    exampleValues: ["Scheduled"],
+    type: {
+        type: "enum",
+        values: ["Scheduled", "InProgress", "Completed", "NotEffective"],
+    },
+});
+export const PRISMANTIX_OAC_VALUE_TYPES = [
+    EpochMillisValueType,
+    IsoTimestampStringValueType,
+    SiteRegionValueType,
+    SiteSiteTypeValueType,
+    SiteStatusValueType,
+    SiteValidationStatusValueType,
+    ProductDevelopmentStageValueType,
+    ProductDosageFormValueType,
+    ProductProductTypeValueType,
+    ProductRegulatoryStatusValueType,
+    ProductTherapeuticAreaValueType,
+    EquipmentStatusValueType,
+    SupplierCategoryValueType,
+    SupplierCertificationStatusValueType,
+    SupplierStatusValueType,
+    SupplierSupplierTypeValueType,
+    BatchBatchSizeUnitValueType,
+    BatchReleaseStatusValueType,
+    BatchStatusValueType,
+    DeviationCategoryValueType,
+    DeviationSeverityValueType,
+    DeviationStatusValueType,
+    ComplaintComplaintTypeValueType,
+    ComplaintReporterTypeValueType,
+    ComplaintSeverityValueType,
+    ComplaintStatusValueType,
+    InvestigationPriorityValueType,
+    InvestigationStatusValueType,
+    InvestigationTypeValueType,
+    CapaCategoryValueType,
+    CapaPriorityValueType,
+    CapaSourceTypeValueType,
+    CapaStatusValueType,
+    CapaTypeValueType,
+    ActionItemStatusValueType,
+    ChangeControlChangeCategoryValueType,
+    ChangeControlGxPImpactValueType,
+    ChangeControlRiskAfterValueType,
+    ChangeControlRiskBeforeValueType,
+    ChangeControlStatusValueType,
+    ChangeControlImpactImpactAreaValueType,
+    ChangeControlImpactImpactSeverityValueType,
+    ChangeControlApprovalDecisionValueType,
+    ChangeControlApprovalRoleValueType,
+    ChangeControlEffectivenessStatusValueType,
+];

package/package.json

@@ -0,0 +1,49 @@
+{
+	"name": "@nyrra/prismantix-oac-pharma",
+	"version": "0.0.1",
+	"description": "Authored Prismantix ontology-as-code source of truth built on @nyrra/maker.",
+	"license": "MIT",
+	"type": "module",
+	"repository": {
+		"type": "git",
+		"url": "git+https://github.com/nyrra-labs/prismantix.git"
+	},
+	"homepage": "https://github.com/nyrra-labs/prismantix#readme",
+	"bugs": {
+		"url": "https://github.com/nyrra-labs/prismantix/issues"
+	},
+	"keywords": [
+		"ontology",
+		"ontology-as-code",
+		"oac",
+		"pharma",
+		"prismantix"
+	],
+	"main": "./dist/index.mjs",
+	"module": "./dist/index.mjs",
+	"types": "./dist/index.d.mts",
+	"exports": {
+		"./package.json": "./package.json",
+		".": {
+			"@prismantix/source": "./src/index.mts",
+			"types": "./dist/index.d.mts",
+			"import": "./dist/index.mjs",
+			"default": "./dist/index.mjs"
+		}
+	},
+	"files": [
+		"dist",
+		"!dist/**/*.map",
+		"!**/*.tsbuildinfo"
+	],
+	"nx": {
+		"name": "prismantix-oac-pharma"
+	},
+	"publishConfig": {
+		"access": "public"
+	},
+	"dependencies": {
+		"@nyrra/maker": "workspace:*",
+		"tslib": "^2.3.0"
+	}
+}