Cobalt58QualityChecker

Cobalt58

radiopharmaceuticals QC URS & FS input.csv output.json radiochemical purity radionuclidic purity

Utility description: Cobalt58

Cobalt58 Quality Checker — radiopharmaceutical QC utility.

Limited source description was provided. The utility shall read input.csv, validate declared fields, apply deterministic acceptance rules defined in the executable and produce output.json for QA/QC review.

input.csv

id,val

URS & FS — User Requirements and Functional Specification

This document describes the controlled interface and behaviour of Cobalt58QualityChecker for Cobalt58.

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.

Critical limits must be defined in the approved specification and implemented in the executable.

URS — User Requirements Specification

ID	Requirement	Criticality	Acceptance criterion
URS-001	The utility shall accept an `input.csv` file with the exact headers defined in the data contract.	High	The file is processed without manual header editing.
URS-002	The utility shall perform deterministic QC evaluation for Cobalt58 using input values, approved limits and domain rules.	High	Each input row receives a `PASS / WARNING / FAIL` status.
URS-003	The utility shall validate mandatory fields, data types, numeric ranges, units and pharmaceutical/radiochemical plausibility.	High	Schema and conversion errors are explicitly reported.
URS-004	The utility shall identify critical deviations related to radionuclidic purity, radiochemical purity, free radionuclide, impurities, pH, endotoxins and sterility when such fields are present.	High	A critical deviation causes FAIL or a separate critical finding.
URS-005	The utility shall generate `output.json` with machine-readable results, source values, warnings and failures.	High	JSON is suitable for LIMS/ELN/MES integration and QA/QC review.
URS-006	The utility shall not use machine learning to decide conformance.	Medium	The result is based on explicit rules, thresholds and input values.
URS-007	The utility shall preserve traceability between batch number, input values, applied rules and final status.	High	The output contains the batch identifier and the list of checked parameters.
URS-008	The documentation shall support IQ/OQ preparation and inspection discussion with FDA/EMA/Roszdravnadzor or local regulators.	Medium	URS & FS, `input.csv`/`output.json` contract and test scenarios are supplied with the utility.

input.csv contract

#	Field	Type	Sample	Purpose
1	`id`	string		Controlled input parameter used by the deterministic QC rules.
2	`val`	string / decimal		Controlled input parameter used by the deterministic QC rules.

id,val

FS — Functional Specification

ID	Function	Implementation
FS-001	CSV import	Read `input.csv` in UTF-8/CSV-compatible format and validate the header and expected columns.
FS-002	Schema validation	Check mandatory fields and column count; report unknown or missing key fields.
FS-003	Type conversion	Convert numeric, flag and text values; invalid formats are recorded as row-level errors.
FS-004	Domain rule engine	Apply domain rules for Cobalt58, including critical limits from the utility description and approved specification.
FS-005	Status aggregation	Produce final status: FAIL for critical failure, WARNING for non-critical deviation, PASS for conformance.
FS-006	JSON export	Write `output.json` with detailed checks, source values, warnings, failures and critical findings.
FS-007	Audit support	Keep the result structure suitable for review, deviation investigation, calculation reproduction and IQ/OQ preparation.
FS-008	Integration contract	Support the production scenario: LIMS/ELN/MES creates `input.csv`, the utility returns `output.json`, the portal displays description and documentation.

Example output.json

{
  "utilityId": "cobalt58-quality-checker",
  "api": "Cobalt58",
  "overallStatus": "PASS|WARNING|FAIL",
  "sourceFile": "input.csv",
  "checks": [
    {
      "parameter": "id",
      "value": "",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    },
    {
      "parameter": "val",
      "value": "",
      "status": "PASS|WARNING|FAIL",
      "message": "Rule-based check result"
    }
  ],
  "criticalFindings": []
}

OQ/PQ test scenarios

ID	Scenario	Expected result
OQ-001	Valid sample row	PASS or acceptable WARNING according to the rules.
OQ-002	Mandatory column missing	Schema error or FAIL.
OQ-003	Non-numeric value in numeric field	Type-conversion error.
OQ-004	Critical parameter outside limit	FAIL and critical finding.
PQ-001	User real batch/lot	Reviewed result with `input.csv` and `output.json` retained.

QA/QC and change control

Do not rename columns without updating the validator 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 radiopharmaceutical limits must be verified against the approved specification and local SOPs.

Included in packages

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QC package for radiology and diagnostic imaging: radiopharmaceuticals, PET/SPECT, contrast media, iodinated and gadolinium products, plus particle, sterility and endotoxin checks.

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RPH use case: generators, isotope purity and starting radionuclides

Control of generator eluate, breakthrough, radionuclidic purity, isotope mix, carrier/free radionuclides and starting radionuclides before labeling.

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RPH workflow: generators and isotope purity

Generator eluate, breakthrough, radionuclidic purity, isotope mix and starting radionuclides.

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RPH workflow: product release QC

Assay, purity, sterility, endotoxins, pH, impurities, appearance and batch-release checks.

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RPH: combined radiopharmaceutical QC package

RPH combines PetRad, PetRad2 and PetRad3 into one umbrella package for PET/SPECT, therapeutic radionuclides, generators, labelled compounds, decay calculations, sterility, endotoxins and radiochemical/radionuclidic purity.

Open