AutologousBatchChainOfIdentityUtility

Autologous Batch Chain of Identity

Vet veterinary veterinary vaccines animal health adjuvants aquaculture batch release CSV→JSON

Utility description: Autologous Batch Chain of Identity

Autologous Batch Chain of Identity Utility — Chain of Identity Verification (ATMP)

ℹ️ Utility performs strict validation of Chain of Identity (COI) and Chain of Custody (COC) for autologous Advanced Therapy Medicinal Products (ATMP) according to FDA 21 CFR Part 1271 and EU Regulation No 1394/2007:
• Patient Identification: Guarantee that material belongs to the specific patient (Patient ID == Donor ID).
• Container Traceability: Link between leukapheresis bag and final product vial.
• Release Quality Control: Check of cell viability, sterility, and mycoplasma absence.
• Temperature Monitoring: Control of Time Out of Controlled Temperature (TOCT).

⚠️ IMPORTANT:
• For autologous therapies, each product is unique and intended for only one specific patient.
• Sample mix-up is a critical deviation that cannot be corrected.

Usage:
AutologousBatchChainOfIdentityUtility.exe → demo mode (console output)
AutologousBatchChainOfIdentityUtility.exe input.csv output.json → evaluate your data

Input format:
PatientID,DonorID,BatchNumber,ProductName,CollectionBagID,FinalProductID,ViabilityCheckPassed,SterilityCheckPassed,MycoplasmaCheckPassed,TimeOutOfControlledTemp_Hours,MaxAllowedTOCT_Hours

Example:
PAT-001,PAT-001,CAR-T-001,Tisa,BAG-1,VIAL-1,true,true,true,1.5,4.0

📍 Scope of Application (Usage Where):
• Cell Therapy Production (CAR-T, TILs): Final check before cryopreservation or shipment to clinic.
• Clinical Use: Verification of patient identity and product before infusion (Bedside Check).
• Regulatory Compliance: Audit of traceability systems for FDA/EMA inspections.
• ATMP Logistics: Control of transport conditions for individual products.

— WHY IS THIS NEEDED?
Unlike mass-produced drugs, autologous products have no "backup" batches. An identity error means losing the only chance for treatment for the patient and risking the administration of foreign biomaterial.
Automation of COI verification eliminates human error when reconciling dozens of barcodes and documents.

⚠️ CRITICAL:
• Patient-Donor Match: For autologous products, these IDs must be identical. Any mismatch blocks release.
• Sterility/Mycoplasma: Positive test result makes product unsuitable for infusion into immunocompromised patients.
• TOCT: Exceeding time out of cold reduces cell viability and therapy efficacy.
• Unique Identifiers: Use of globally unique IDs (GUID) is mandatory at all stages.

Key features:
• Automatic reconciliation of patient and donor identifiers
• Integrity check of "Collection-Production-Final Product" link
• Integration of QC parameters (Viability, Sterility) into release decision
• Temperature limit control (TOCT)
• Audit trail generation for regulatory authorities

Critical parameters:
• Patient ID: Must match Donor ID
• Collection/Final Bag IDs: Must be linked in system
• Viability: Typically >70-80%
• Sterility/Mycoplasma: Negative only
• TOCT: Strictly within validated window

💡 Usage tips:
1. Barcode Scanning: Use scanners to minimize manual ID entry.
2. Double Check: Implement independent verification procedure in clinic.
3. Backup: COI data must be stored in a secure database with restricted access.
4. Personnel Training: Medical staff must understand the importance of each verification step.
5. Immediate Response: Upon MISMATCH status, product must be immediately quarantined.

⚠️ Note: This utility is a critical element of ATMP quality system. It does not replace clinical observation but ensures technical safety of personalized therapy application.

input.csv

PatientID,DonorID,BatchNumber,ProductName,CollectionBagID,FinalProductID,ViabilityCheckPassed,SterilityCheckPassed,MycoplasmaCheckPassed,TimeOutOfControlledTemp_Hours,MaxAllowedTOCT_Hours
PAT-2026-001,PAT-2026-001,CAR-T-2026-001,Tisagenlecleucel,BAG-LEU-889,VIAL-CAR-889,true,true,true,1.5,4.0
PAT-2026-002,PAT-2026-002,CAR-T-2026-002,Axicabtagene Ciloleucel,BAG-LEU-902,VIAL-CAR-902,true,false,true,2.0,4.0

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of AutologousBatchChainOfIdentityUtility for Autologous Batch Chain of Identity Utility.

Domain limits URS input.csv FS IQ/OQ/PQ

Domain limits and critical parameters

Key fragments from the source description are shown below. Before production use, limits must be verified against the approved specification, registration dossier and local SOPs.

• Sample mix-up is a critical deviation that cannot be corrected.
⚠️ CRITICAL:
• Patient-Donor Match: For autologous products, these IDs must be identical. Any mismatch blocks release.
• Temperature limit control (TOCT)
Critical parameters:
• Patient ID: Must match Donor ID
• Collection/Final Bag IDs: Must be linked in system
• Viability: Typically >70-80%
3. Backup: COI data must be stored in a secure database with restricted access.
4. Personnel Training: Medical staff must understand the importance of each verification step.
5. Immediate Response: Upon MISMATCH status, product must be immediately quarantined.
⚠️ Note: This utility is a critical element of ATMP quality system. It does not replace clinical observation but ensures technical safety of personalized therapy application.

URS — User Requirements Specification

ID	Requirement	Criticality	Acceptance criterion
URS-001	The utility shall accept an input.csv file for Autologous Batch Chain of Identity Utility with headers defined in the data contract.	High	The file is processed without manual header editing.
URS-002	The utility shall perform deterministic QC evaluation without machine learning and without probabilistic conformance decisions.	High	Identical input data, rule version and configuration produce reproducible results.
URS-003	The utility shall validate mandatory fields, data types, ranges, units and domain plausibility.	High	Schema, conversion and range errors are explicitly reported.
URS-004	The utility shall apply domain limits and rules from the description, approved specification, registration dossier and local SOPs.	High	Each check has PASS/WARNING/FAIL and a clear message.
URS-005	The utility shall generate output.json with machine-readable results, source values, warnings, failures and critical findings.	High	JSON is suitable for LIMS/ELN/MES integration and QA/QC review.
URS-006	The utility shall preserve traceability between batch/sample, input file, applied rules and final status.	High	Output contains identifiers, checked parameters and audit metadata.
URS-007	The documentation shall support IQ/OQ/PQ, CSV/CSA and review by internal QA or inspectors.	Medium	URS, FS, input/output contract and test scenarios are supplied with the utility.
URS-008	The utility shall be used as a QC decision-support tool and not as a substitute for approved specifications and QA/QP release decision.	Medium	Documentation states change control and limit-verification expectations.

input.csv contract

#	Field	Type	Sample	Purpose
1	`PatientID`	string / controlled vocabulary	`PAT-2026-001`	Controlled input parameter for deterministic QC rules.
2	`DonorID`	string / controlled vocabulary	`PAT-2026-001`	Controlled input parameter for deterministic QC rules.
3	`BatchNumber`	string / controlled vocabulary	`CAR-T-2026-001`	Batch or lot identifier used for traceability.
4	`ProductName`	string / controlled vocabulary	`Tisagenlecleucel`	Product or dosage-form name under evaluation.
5	`CollectionBagID`	string / controlled vocabulary	`BAG-LEU-889`	Controlled input parameter for deterministic QC rules.
6	`FinalProductID`	string / controlled vocabulary	`VIAL-CAR-889`	Product or dosage-form name under evaluation.
7	`ViabilityCheckPassed`	string / controlled vocabulary	`true`	Controlled input parameter for deterministic QC rules.
8	`SterilityCheckPassed`	string / controlled vocabulary	`true`	Sterility or related absence-of-growth control.
9	`MycoplasmaCheckPassed`	string / controlled vocabulary	`true`	Controlled input parameter for deterministic QC rules.
10	`TimeOutOfControlledTemp_Hours`	integer / decimal	`1.5`	Temperature profile/MKT; storage, shipping and stability parameter.
11	`MaxAllowedTOCT_Hours`	integer / decimal	`4.0`	Time parameter for process, incubation, storage or analytical workflow.

PatientID,DonorID,BatchNumber,ProductName,CollectionBagID,FinalProductID,ViabilityCheckPassed,SterilityCheckPassed,MycoplasmaCheckPassed,TimeOutOfControlledTemp_Hours,MaxAllowedTOCT_Hours
PAT-2026-001,PAT-2026-001,CAR-T-2026-001,Tisagenlecleucel,BAG-LEU-889,VIAL-CAR-889,true,true,true,1.5,4.0
PAT-2026-002,PAT-2026-002,CAR-T-2026-002,Axicabtagene Ciloleucel,BAG-LEU-902,VIAL-CAR-902,true,false,true,2.0,4.0

Input validation rules

ID	Field	Rule	Criticality
VR-001	`PatientID`	The field shall match an approved dictionary or accepted string representation.	High
VR-002	`DonorID`	The field shall match an approved dictionary or accepted string representation.	High
VR-003	`BatchNumber`	The field shall match an approved dictionary or accepted string representation.	High
VR-004	`ProductName`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-005	`CollectionBagID`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-006	`FinalProductID`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-007	`ViabilityCheckPassed`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-008	`SterilityCheckPassed`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-009	`MycoplasmaCheckPassed`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-010	`TimeOutOfControlledTemp_Hours`	The field shall match an approved dictionary or accepted string representation.	Medium
VR-011	`MaxAllowedTOCT_Hours`	The field shall match an approved dictionary or accepted string representation.	Medium

FS — Functional Specification

ID	Function	Implementation
FS-001	CLI execution	Support execution modes: demo mode without arguments and production mode input.csv output.json.
FS-002	CSV import	Read input.csv in UTF-8/CSV-compatible format and validate header and expected columns.
FS-003	Schema validation	Check mandatory fields, column count, unknown key fields and empty mandatory values.
FS-004	Type conversion	Convert numeric, flag and text values; invalid format is recorded as a row-level error.
FS-005	Domain rule engine	Apply rules for Autologous Batch Chain of Identity Utility, including critical limits from the description and approved specification.
FS-006	Status aggregation	Produce final status: FAIL for critical failure, WARNING for non-critical deviation, PASS for conformance.
FS-007	JSON export	Write output.json with detailed checks, source values, warnings, failures and critical findings.
FS-008	Audit support	Keep result structure suitable for review, deviation investigation and calculation reproduction.
FS-009	Integration contract	Support the scenario LIMS/ELN/MES → input.csv → utility → output.json → portal/admin review.
FS-010	Error handling	Return explicit messages for missing file, empty CSV, invalid schema, output write failure and invalid format.

Example output.json

{
  "utilityId": "autologousbatchchainofidentityutility",
  "utilityFolder": "AutologousBatchChainOfIdentityUtility",
  "package": "Vet",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "processedAtUtc": "2026-06-10T00:00:00Z",
  "checks": [
    {
      "parameter": "PatientID",
      "value": "PAT-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-001"
    },
    {
      "parameter": "DonorID",
      "value": "PAT-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-002"
    },
    {
      "parameter": "BatchNumber",
      "value": "CAR-T-2026-001",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-003"
    },
    {
      "parameter": "ProductName",
      "value": "Tisagenlecleucel",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-004"
    },
    {
      "parameter": "CollectionBagID",
      "value": "BAG-LEU-889",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-005"
    },
    {
      "parameter": "FinalProductID",
      "value": "VIAL-CAR-889",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-006"
    },
    {
      "parameter": "ViabilityCheckPassed",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-007"
    },
    {
      "parameter": "SterilityCheckPassed",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-008"
    },
    {
      "parameter": "MycoplasmaCheckPassed",
      "value": "true",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-009"
    },
    {
      "parameter": "TimeOutOfControlledTemp_Hours",
      "value": "1.5",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-010"
    },
    {
      "parameter": "MaxAllowedTOCT_Hours",
      "value": "4.0",
      "status": "PASS|WARNING|FAIL",
      "message": "Deterministic rule-based check result",
      "ruleReference": "FS-RULE-011"
    }
  ],
  "criticalFindings": [],
  "warnings": [],
  "audit": {
    "inputHash": "sha256:<calculated at runtime>",
    "rulesVersion": "<utility executable version>",
    "documentation": "AutologousBatchChainOfIdentityUtility.documentation.html"
  }
}

Traceability matrix

URS	FS	Test	Evidence
URS-001	FS-001, FS-002	OQ-001	Verify execution and import of valid input.csv.
URS-002	FS-005, FS-006	OQ-004	Repeat the same dataset and compare output.json.
URS-003	FS-003, FS-004, FS-010	OQ-002, OQ-003	Verify missing columns and invalid types.
URS-004	FS-005, FS-006	OQ-004, PQ-001	Verify critical deviations on real/boundary data.
URS-005	FS-007, FS-009	OQ-005	Verify JSON schema and downstream-system suitability.
URS-006	FS-008	OQ-006	Verify identifiers and audit metadata.
URS-007	FS-008, FS-010	IQ-001, OQ-007	Verify documentation completeness and control evidence.
URS-008	FS-005, FS-008	PQ-002	Verify review workflow and no replacement of QA decision.

IQ/OQ/PQ test scenarios

ID	Scenario	Expected result
IQ-001	Verify executable, input.csv, documentation and checksum availability.	Delivery set is complete; version is recorded.
OQ-001	Valid sample row from input.csv.	PASS or acceptable WARNING according to rules.
OQ-002	Remove a mandatory CSV column.	Schema error or FAIL with missing-column reference.
OQ-003	Place a non-numeric value into a numeric field.	Type-conversion error with row/field reference.
OQ-004	Set a critical parameter outside the limit.	FAIL and critical finding.
OQ-005	Verify output.json structure.	All mandatory sections are present and JSON is valid.
OQ-006	Verify batch/sample traceability.	Input and result identifiers match.
PQ-001	Verify 3–5 real user batches/samples.	Result is confirmed by QC/QA review.
PQ-002	Verify deviation workflow and manual QA decision.	Utility supports review but does not replace approved decision.

QA/QC and change control

Do not rename columns without updating validator, documentation and test set.
Retain input.csv, output.json, executable version and checksum.
Before production use, perform IQ/OQ/PQ or equivalent CSV/CSA verification.
Critical limits shall be verified against the approved specification, registration dossier and local SOPs.
The utility provides structured QC decision support; final release decision remains with QA/QP and approved procedures.

Included in packages

Vet — Veterinary QC Utilities

Vet is designed for veterinary pharmaceuticals and vaccines: adjuvants, antigens, autogenous vaccines, aquaculture, feed/premixes, antimicrobial and antiparasitic products, sterility and batch release.

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