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Instrumental:Medical Devices — from Lumex/LabEx to lifecycle utilities

For every Lumex/LabEx utility, the article maps Medical Devices utilities for QMS, risk, software, cybersecurity, calibration, sterile consumables and validated data flow.

Instrumental:Medical Devices — from Lumex/LabEx to lifecycle utilities

For every Lumex/LabEx utility, the article shows which Medical Devices utilities may support the related instrument, workstation, CDS/software, IVD system, consumables and validated data flow.

167Lumex/LabEx utilities
121Medical Devices utilities
12maximum mappings
Medical Devices utilities do not replace pharmacopoeial control. They cover the non-pharmacopoeial lifecycle: QMS, risk, software, cybersecurity, electrical/EMC, sterile consumables, packaging and evidence traceability.

Cross-cutting Medical Devices utilities

Some utilities do not correspond to one analytical instrument. They may be needed for any HPLC, GC, CE, ICP, spectroscopy, microbiology or other system when at least one condition applies:

  1. the instrument has embedded software, a workstation or a chromatography data system;
  2. results are transferred to LIMS, LabWare, MES, QMS or a cloud service;
  3. firmware, method templates, calculations or configuration changes affect the validated state;
  4. supplier qualification, calibration, CAPA, change control, risk management or traceability evidence is required.

How to read the mapping

The mapping is based on analytical-result type and manufacturing context, not on a claim that every instrument automatically fits every product. A real chain usually follows: equipment/method → instrumental utility → product/API specification or Medical Devices lifecycle evidence.

A

AAS Aluminum Limit Test
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AAS Catalyst Residues Pd Pt Rh
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AAS Dialysis Fluid Monitor
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AAS Dialysis Solution Metals
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AAS Elemental Impurities Class1
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AAS Elemental Impurities Class2A
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AAS Elemental Impurities Class2B
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AAS Glass Leachables Test
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AAS Heavy Metals Plant Material
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AAS Microelements Supplements
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AAS Nickel Hydrogenated Oils
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AcyclovirImpurityChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AmlodipineBesylateChiralChecker
Assay and impuritiesChiral purity

For the Assay and impurities, Chiral purity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

AmoxicillinDegradationChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Assay & Impurity HPLC Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Automated Liquid Handling QC Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Automated Sterility Detection Quality Checker
Sterility

For the Sterility method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

B

Bacterial Endotoxins LAL Quality Checker
Endotoxins

For the Endotoxins method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Bacterial Endotoxins Recombinant Quality Checker
EndotoxinsProteins and biologics

For the Endotoxins, Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Biologic Aggregate Size Quality Checker
Particles and sizeProteins and biologics

For the Particles and size, Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

C

Capillary ID Aprotinin
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Capillary ID Galantamine
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Capillary ID Glutathione
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Capillary ID SodiumLaurylSulfoacetate
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CE Chiral Separation Checker
Chiral purity

For the Chiral purity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CE DNA Vaccine Purity Checker
Assay and impuritiesDNA/RNA and vectorsVaccines

For the Assay and impurities, DNA/RNA and vectors, Vaccines method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CE Erythropoietin Isoform Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CE Glycosylation Profiler
Proteins and biologics

For the Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CE Inorganic Ions Analyzer
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CE mAb Aggregates Fragments
Proteins and biologics

For the Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CE mAb Charge Variant Checker
Proteins and biologics

For the Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CE Peptide Map Fingerprint
Peptides

For the Peptides method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CE Peptide Map Validator
Peptides

For the Peptides method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CE Recombinant Protein Purity
Assay and impuritiesProteins and biologics

For the Assay and impurities, Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CeftriaxoneSodiumPurityChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Charge Variant CE Quality Checker
Proteins and biologics

For the Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Chiral Purity HPLC Quality Checker
Assay and impuritiesChiral purity

For the Assay and impurities, Chiral purity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

ChondroitinSulfateAssayChecker
Assay and impuritiesProteins and biologics

For the Assay and impurities, Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CiprofloxacinImpurityChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Circular Dichroism Biologic Quality Checker
Spectroscopic identityProteins and biologics

For the Spectroscopic identity, Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

CollagenHydrolysatePeptideProfileChecker
Proteins and biologicsPeptides

For the Proteins and biologics, Peptides method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Content Uniformity Acceptance Value
Content uniformity

For the Content uniformity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Content Uniformity Quality Checker
Content uniformity

For the Content uniformity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

D

DaclatasvirAssayChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Delivered Dose Uniformity Inhaler Quality Checker
Inhalation products

For the Inhalation products method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Density & Refractive Index Quality Checker
Physicochemical parameters

For the Physicochemical parameters method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Disintegration Tablet/Capsule Quality Checker
Disintegration

For the Disintegration method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Dissolution Apparatus 1 & 2 Quality Checker
Dissolution

For the Dissolution method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Dissolution Extended Release Quality Checker
Dissolution

For the Dissolution method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Dissolution Profile f2 Calculator
Dissolution

For the Dissolution method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

DrotaverineHydrochlorideChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

E

Elemental Impurities ICP Quality Checker
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

ELISA Bioassay Quality Checker
Assay and impuritiesProteins and biologics

For the Assay and impurities, Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Endotoxin Biologic Product Quality Checker
EndotoxinsProteins and biologics

For the Endotoxins, Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Environmental Monitoring Cleanroom Quality Checker
Microbiology

For the Microbiology method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Excipient Incoming QC Library
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Excipients Sugars Polyols HPLC
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

F

Filter Integrity Test Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

FluconazoleRelatedSubstancesChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Fluorat Aflatoxin Screener
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Fluorat Aluminum Vaccines
Spectroscopic identityVaccines

For the Spectroscopic identity, Vaccines method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Fluorat B Complex Vitamins
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Fluorat Enzyme Fluorogenic Assays
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Fluorat Mycotoxins Ochratoxin
Pesticides and mycotoxins

For the Pesticides and mycotoxins method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Fluorat Nucleic Acids Quantifier
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Fluorat Porphyrin Checker
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Fluorat Quinine Sulfate Checker
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Fluorat Reactive Oxygen Species
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Fluorat Riboflavin Quantifier
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Fluorescence Spectroscopy Quality Checker
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

FTIR Identity Quality Checker
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

G

GC-MS Screening Volatile Impurities Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Genotoxic Impurity Screener M7
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

GlucosamineSulfatePurityChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

H

Heavy Metals Limit Test Quality Checker
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

HeparinSodiumMolecularWeightChecker
Proteins and biologics

For the Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

HyaluronicAcidMolecularWeightChecker
Proteins and biologics

For the Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

I

IbuprofenRelatedSubstancesChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Acyclovir
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Amlodipine
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Amoxicillin
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Ceftriaxone
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Ciprofloxacin
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Daclatasvir
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Drotaverine
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Fluconazole
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Ibuprofen
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Levofloxacin
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Losartan
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Metformin
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Omeprazole
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Paracetamol
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Ranitidine
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Ribavirin
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InfraLUM ID Sofosbuvir
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Inhalation APSD Quality Checker
Inhalation products

For the Inhalation products method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

InsulinHumanHPLCChecker
Assay and impuritiesProteins and biologics

For the Assay and impurities, Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

L

LabWare CDS Bridge Connector
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

LC-MS Confirmation Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

LevofloxacinOpticalIsomerChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

LosartanPotassiumImpurityChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Loss On Drying Quality Checker
Water and moisture

For the Water and moisture method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

M

Melting Point Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Mercury Analyzer Fish Oil
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Mercury Analyzer Vaccine Thimerosal
Elemental impurities and metalsVaccines

For the Elemental impurities and metals, Vaccines method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Mercury Analyzer Water Hemodialysis
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Mercury Speciation Methyl vs Inorganic
Elemental impurities and metals

For the Elemental impurities and metals method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

MetforminHydrochloridePurityChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Method Validation Data Packager
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

MethylparabenPropylparabenChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Microbial Enumeration (TAMC/TYMC) Quality Checker
Microbiology

For the Microbiology method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Microbial Identification System Quality Checker
Microbiology

For the Microbiology method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Microwave Digestion Prep Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Moisture Sorption Isotherm Processor
Water and moisture

For the Water and moisture method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

N

NIR API Content Checker
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

NIR Blend Uniformity Checker
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

NIR Moisture Content Checker
Water and moistureSpectroscopic identity

For the Water and moisture, Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

NIR RealTime Blend Endpoint
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

NMR Structure Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

O

OmeprazoleAssayChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Osmolality Quality Checker
Physicochemical parameters

For the Physicochemical parameters method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Outlier Detection Grubb Dixon
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

P

Package Integrity & Leak Test Quality Checker
Packaging and integrity

For the Packaging and integrity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

ParacetamolImpurityChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Particle Count Injection USP <788> Quality Checker
Particles and size

For the Particles and size method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

pH & Conductivity Water Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

PolyethyleneGlycolImpurityChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Polymer ID EVA
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Polymer ID Polyethylene
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Polymer ID Polypropylene
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Polymorph Screening NIR FTIR
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Polysorbate80PeroxideChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Potentiometric Titration Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Powder Flow Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Preparative LC Fraction Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Preservatives Combo QC
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Protein Concentration UV Quality Checker
Proteins and biologics

For the Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Pyrogen Test (Rabbit & MAT) Quality Checker
Endotoxins

For the Endotoxins method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

R

Raman Identity Quality Checker
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

RanitidineImpurityChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Rapid Micro Alternative Method Quality Checker
MicrobiologyDNA/RNA and vectors

For the Microbiology, DNA/RNA and vectors method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Residual Solvents GC Quality Checker
Residual solvents

For the Residual solvents method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

RibavirinPurityChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

S

Sample Prep Homogenization Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Semisolid IVRT Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

SodiumBenzoatePreservativeChecker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

SofosbuvirImpurityProfiler
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Specified Microorganisms Quality Checker
Microbiology

For the Microbiology method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

SPR Binding Affinity Quality Checker
Proteins and biologics

For the Proteins and biologics method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Stability Condition Monitoring Quality Checker
Stability

For the Stability method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Stability Shelf Life Predictor
Stability

For the Stability method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Sterility Test Membrane Filtration Quality Checker
System Suitability Parameters Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

T

Tablet Coating Uniformity NIR
Spectroscopic identity

For the Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Tablet Hardness & Friability Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Thermal Analysis DSC/TGA Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

TOC Water Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

U

UV-Vis Identity & Assay Quality Checker
Assay and impuritiesSpectroscopic identity

For the Assay and impurities, Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

V

Viscosity & Rheology Quality Checker
Physicochemical parameters

For the Physicochemical parameters method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

VitaminAQuantifier
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

VitaminD3Quantifier
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

VitaminEQuantifier
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

W

Water Activity Quality Checker
Physicochemical parameters

For the Physicochemical parameters method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Water Content KF Quality Checker
Water and moisture

For the Water and moisture method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Water Microbiology Quality Checker
Microbiology

For the Microbiology method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Weight Variation Tablet/Capsule Quality Checker
Assay and impurities

For the Assay and impurities method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

X

XRPD Polymorph Quality Checker
Physicochemical parametersSpectroscopic identity

For the Physicochemical parameters, Spectroscopic identity method, Medical Devices utilities address equipment and software lifecycle: supplier control, calibration, change/validation evidence, data integrity and, for an IVD/device-like system, risk, electrical safety, EMC and software lifecycle.

Utilities and checked parameters

#API / productUtilityKey checks
1aas-aluminum-limit-testaas aluminum limit testDeterministic QC check from CSV input with JSON output for QA/QC review.
2aas-catalyst-residues-pd-pt-rhaas catalyst residues pd pt rhDeterministic QC check from CSV input with JSON output for QA/QC review.
3aas-dialysis-fluid-monitoraas dialysis fluid monitorDeterministic QC check from CSV input with JSON output for QA/QC review.
4aas-dialysis-solution-metalsaas dialysis solution metalsDeterministic QC check from CSV input with JSON output for QA/QC review.
5aas-elemental-impurities-class1aas elemental impurities class1Deterministic QC check from CSV input with JSON output for QA/QC review.
6aas-elemental-impurities-class2-aaas elemental impurities class2 aDeterministic QC check from CSV input with JSON output for QA/QC review.
7aas-elemental-impurities-class2-baas elemental impurities class2 bDeterministic QC check from CSV input with JSON output for QA/QC review.
8aas-glass-leachables-testaas glass leachables testDeterministic QC check from CSV input with JSON output for QA/QC review.
9aas-heavy-metals-plant-materialaas heavy metals plant materialDeterministic QC check from CSV input with JSON output for QA/QC review.
10aas-microelements-supplementsaas microelements supplementsDeterministic QC check from CSV input with JSON output for QA/QC review.
11aas-nickel-hydrogenated-oilsaas nickel hydrogenated oilsDeterministic QC check from CSV input with JSON output for QA/QC review.
12acyclovir-impurity-checkeracyclovir impurity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
13amlodipine-besylate-chiral-checkeramlodipine besylate chiral checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
14amoxicillin-degradation-checkeramoxicillin degradation checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
15assay-impurity-hplcquality-checkerassay impurity hplcquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
16authentication-authorization-control-checkerauthentication authorization control checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
17automated-liquid-handling-qcquality-checkerautomated liquid handling qcquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
18automated-sterility-detection-quality-checkerautomated sterility detectionDeterministic QC check from CSV input with JSON output for QA/QC review.
19bacterial-endotoxins-lalquality-checkerbacterial endotoxins lalquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
20bacterial-endotoxins-recombinant-quality-checkerbacterial endotoxins recombinantDeterministic QC check from CSV input with JSON output for QA/QC review.
21benefit-risk-assessment-checkerbenefit risk assessment checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
22bioburden-trend-checkerbioburden trend checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
23biologic-aggregate-size-quality-checkerbiologic aggregate sizeDeterministic QC check from CSV input with JSON output for QA/QC review.
24calibration-schedule-checkercalibration schedule checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
25calibration-status-checkercalibration status checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
26capillary-id-aprotinincapillary id aprotininDeterministic QC check from CSV input with JSON output for QA/QC review.
27capillary-id-galantaminecapillary id galantamineDeterministic QC check from CSV input with JSON output for QA/QC review.
28capillary-id-glutathionecapillary id glutathioneDeterministic QC check from CSV input with JSON output for QA/QC review.
29capillary-id-sodium-lauryl-sulfoacetatecapillary id sodium lauryl sulfoacetateDeterministic QC check from CSV input with JSON output for QA/QC review.
30ce-chiral-separation-checkerce chiral separation checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
31ce-dna-vaccine-purity-checkerce dna vaccine purity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
32ce-erythropoietin-isoform-checkerce erythropoietin isoform checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
33ce-glycosylation-profilerce glycosylation profilerDeterministic QC check from CSV input with JSON output for QA/QC review.
34ce-inorganic-ions-analyzerce inorganic ions analyzerDeterministic QC check from CSV input with JSON output for QA/QC review.
35ce-m-ab-aggregates-fragmentsce m ab aggregates fragmentsDeterministic QC check from CSV input with JSON output for QA/QC review.
36ce-m-ab-charge-variant-checkerce m ab charge variant checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
37ce-peptide-map-fingerprintce peptide map fingerprintDeterministic QC check from CSV input with JSON output for QA/QC review.
38ce-peptide-map-validatorce peptide map validatorDeterministic QC check from CSV input with JSON output for QA/QC review.
39ce-recombinant-protein-purityce recombinant protein purityDeterministic QC check from CSV input with JSON output for QA/QC review.
40ceftriaxone-sodium-purity-checkerceftriaxone sodium purity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
41change-control-impact-checkerchange control impact checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
42charge-variant-cequality-checkercharge variant cequality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
43chemical-characterization-coverage-checkerchemical characterization coverage checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
44chiral-purity-hplcquality-checkerchiral purity hplcquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
45chondroitin-sulfate-assay-checkerchondroitin sulfate assay checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
46ciprofloxacin-impurity-checkerciprofloxacin impurity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
47circular-dichroism-biologic-quality-checkercircular dichroism biologicDeterministic QC check from CSV input with JSON output for QA/QC review.
48collagen-hydrolysate-peptide-profile-checkercollagen hydrolysate peptide profile checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
49configuration-baseline-checkerconfiguration baseline checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
50content-uniformity-acceptance-valuecontent uniformity acceptance valueDeterministic QC check from CSV input with JSON output for QA/QC review.
51content-uniformity-quality-checkercontent uniformityDeterministic QC check from CSV input with JSON output for QA/QC review.
52cybersecurity-risk-assessment-checkercybersecurity risk assessment checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
53daclatasvir-assay-checkerdaclatasvir assay checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
54data-integrity-security-checkerdata integrity security checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
55delivered-dose-uniformity-inhaler-quality-checkerdelivered dose uniformity inhalerDeterministic QC check from CSV input with JSON output for QA/QC review.
56density-refractive-index-quality-checkerdensity refractive indexDeterministic QC check from CSV input with JSON output for QA/QC review.
57disintegration-tablet-capsule-quality-checkerdisintegration tablet capsuleDeterministic QC check from CSV input with JSON output for QA/QC review.
58dissolution-apparatus12-quality-checkerdissolution apparatus12Deterministic QC check from CSV input with JSON output for QA/QC review.
59dissolution-extended-release-quality-checkerdissolution extended releaseDeterministic QC check from CSV input with JSON output for QA/QC review.
60dissolution-profile-f2-calculatordissolution profile f2 calculatorDeterministic QC check from CSV input with JSON output for QA/QC review.
61drotaverine-hydrochloride-checkerdrotaverine hydrochloride checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
62electrical-safety-test-summary-checkerelectrical safety test summary checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
63elemental-impurities-icpquality-checkerelemental impurities icpquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
64elisabioassay-quality-checkerelisabioassayDeterministic QC check from CSV input with JSON output for QA/QC review.
65endotoxin-biologic-product-quality-checkerendotoxin biologic productDeterministic QC check from CSV input with JSON output for QA/QC review.
66environmental-monitoring-cleanroom-quality-checkerenvironmental monitoring cleanroomDeterministic QC check from CSV input with JSON output for QA/QC review.
67excipient-incoming-qc-libraryexcipient incoming qc libraryDeterministic QC check from CSV input with JSON output for QA/QC review.
68excipients-sugars-polyols-hplcexcipients sugars polyols hplcDeterministic QC check from CSV input with JSON output for QA/QC review.
69filter-integrity-test-quality-checkerfilter integrity testDeterministic QC check from CSV input with JSON output for QA/QC review.
70fluconazole-related-substances-checkerfluconazole related substances checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
71fluorat-aflatoxin-screenerfluorat aflatoxin screenerDeterministic QC check from CSV input with JSON output for QA/QC review.
72fluorat-aluminum-vaccinesfluorat aluminum vaccinesDeterministic QC check from CSV input with JSON output for QA/QC review.
73fluorat-b-complex-vitaminsfluorat b complex vitaminsDeterministic QC check from CSV input with JSON output for QA/QC review.
74fluorat-enzyme-fluorogenic-assaysfluorat enzyme fluorogenic assaysDeterministic QC check from CSV input with JSON output for QA/QC review.
75fluorat-mycotoxins-ochratoxinfluorat mycotoxins ochratoxinDeterministic QC check from CSV input with JSON output for QA/QC review.
76fluorat-nucleic-acids-quantifierfluorat nucleic acids quantifierDeterministic QC check from CSV input with JSON output for QA/QC review.
77fluorat-porphyrin-checkerfluorat porphyrin checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
78fluorat-quinine-sulfate-checkerfluorat quinine sulfate checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
79fluorat-reactive-oxygen-speciesfluorat reactive oxygen speciesDeterministic QC check from CSV input with JSON output for QA/QC review.
80fluorat-riboflavin-quantifierfluorat riboflavin quantifierDeterministic QC check from CSV input with JSON output for QA/QC review.
81fluorescence-spectroscopy-quality-checkerfluorescence spectroscopyDeterministic QC check from CSV input with JSON output for QA/QC review.
82ftiridentity-quality-checkerftiridentityDeterministic QC check from CSV input with JSON output for QA/QC review.
83gcmsscreening-volatile-impurities-quality-checkergcmsscreening volatile impuritiesDeterministic QC check from CSV input with JSON output for QA/QC review.
84genotoxic-impurity-screener-m7genotoxic impurity screener m7Deterministic QC check from CSV input with JSON output for QA/QC review.
85glucosamine-sulfate-purity-checkerglucosamine sulfate purity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
86hazard-analysis-quality-checkerhazard analysisDeterministic QC check from CSV input with JSON output for QA/QC review.
87hazard-identification-completeness-checkerhazard identification completeness checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
88heavy-metals-limit-test-quality-checkerheavy metals limit testDeterministic QC check from CSV input with JSON output for QA/QC review.
89heparin-sodium-molecular-weight-checkerheparin sodium molecular weight checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
90hyaluronic-acid-molecular-weight-checkerhyaluronic acid molecular weight checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
91ibuprofen-related-substances-checkeribuprofen related substances checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
92incoming-inspection-sampling-checkerincoming inspection sampling checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
93infra-lum-id-acyclovirinfra lum id acyclovirDeterministic QC check from CSV input with JSON output for QA/QC review.
94infra-lum-id-amlodipineinfra lum id amlodipineDeterministic QC check from CSV input with JSON output for QA/QC review.
95infra-lum-id-amoxicillininfra lum id amoxicillinDeterministic QC check from CSV input with JSON output for QA/QC review.
96infra-lum-id-ceftriaxoneinfra lum id ceftriaxoneDeterministic QC check from CSV input with JSON output for QA/QC review.
97infra-lum-id-ciprofloxacininfra lum id ciprofloxacinDeterministic QC check from CSV input with JSON output for QA/QC review.
98infra-lum-id-daclatasvirinfra lum id daclatasvirDeterministic QC check from CSV input with JSON output for QA/QC review.
99infra-lum-id-drotaverineinfra lum id drotaverineDeterministic QC check from CSV input with JSON output for QA/QC review.
100infra-lum-id-fluconazoleinfra lum id fluconazoleDeterministic QC check from CSV input with JSON output for QA/QC review.
101infra-lum-id-ibuprofeninfra lum id ibuprofenDeterministic QC check from CSV input with JSON output for QA/QC review.
102infra-lum-id-levofloxacininfra lum id levofloxacinDeterministic QC check from CSV input with JSON output for QA/QC review.
103infra-lum-id-losartaninfra lum id losartanDeterministic QC check from CSV input with JSON output for QA/QC review.
104infra-lum-id-metformininfra lum id metforminDeterministic QC check from CSV input with JSON output for QA/QC review.
105infra-lum-id-omeprazoleinfra lum id omeprazoleDeterministic QC check from CSV input with JSON output for QA/QC review.
106infra-lum-id-paracetamolinfra lum id paracetamolDeterministic QC check from CSV input with JSON output for QA/QC review.
107infra-lum-id-ranitidineinfra lum id ranitidineDeterministic QC check from CSV input with JSON output for QA/QC review.
108infra-lum-id-ribavirininfra lum id ribavirinDeterministic QC check from CSV input with JSON output for QA/QC review.
109infra-lum-id-sofosbuvirinfra lum id sofosbuvirDeterministic QC check from CSV input with JSON output for QA/QC review.
110inhalation-apsdquality-checkerinhalation apsdquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
111insulin-human-hplccheckerinsulin human hplccheckerDeterministic QC check from CSV input with JSON output for QA/QC review.
112integration-test-coverage-checkerintegration test coverage checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
113lab-ware-cds-bridge-connectorlab ware cds bridge connectorDeterministic QC check from CSV input with JSON output for QA/QC review.
114lcmsconfirmation-quality-checkerlcmsconfirmationDeterministic QC check from CSV input with JSON output for QA/QC review.
115levofloxacin-optical-isomer-checkerlevofloxacin optical isomer checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
116losartan-potassium-impurity-checkerlosartan potassium impurity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
117loss-on-drying-quality-checkerloss on dryingDeterministic QC check from CSV input with JSON output for QA/QC review.
118melting-point-quality-checkermelting pointDeterministic QC check from CSV input with JSON output for QA/QC review.
119mercury-analyzer-fish-oilmercury analyzer fish oilDeterministic QC check from CSV input with JSON output for QA/QC review.
120mercury-analyzer-vaccine-thimerosalmercury analyzer vaccine thimerosalDeterministic QC check from CSV input with JSON output for QA/QC review.
121mercury-analyzer-water-hemodialysismercury analyzer water hemodialysisDeterministic QC check from CSV input with JSON output for QA/QC review.
122mercury-speciation-methyl-vs-inorganicmercury speciation methyl vs inorganicDeterministic QC check from CSV input with JSON output for QA/QC review.
123metformin-hydrochloride-purity-checkermetformin hydrochloride purity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
124method-validation-data-packagermethod validation data packagerDeterministic QC check from CSV input with JSON output for QA/QC review.
125methylparaben-propylparaben-checkermethylparaben propylparaben checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
126microbial-enumeration-tamctymcquality-checkermicrobial enumeration tamctymcquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
127microbial-identification-system-quality-checkermicrobial identification systemDeterministic QC check from CSV input with JSON output for QA/QC review.
128microwave-digestion-prep-quality-checkermicrowave digestion prepDeterministic QC check from CSV input with JSON output for QA/QC review.
129moisture-sorption-isotherm-processormoisture sorption isotherm processorDeterministic QC check from CSV input with JSON output for QA/QC review.
130nir-api-content-checkernir api content checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
131nir-blend-uniformity-checkernir blend uniformity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
132nir-moisture-content-checkernir moisture content checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
133nir-real-time-blend-endpointnir real time blend endpointDeterministic QC check from CSV input with JSON output for QA/QC review.
134nmrstructure-quality-checkernmrstructureDeterministic QC check from CSV input with JSON output for QA/QC review.
135omeprazole-assay-checkeromeprazole assay checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
136osmolality-quality-checkerosmolalityDeterministic QC check from CSV input with JSON output for QA/QC review.
137outlier-detection-grubb-dixonoutlier detection grubb dixonDeterministic QC check from CSV input with JSON output for QA/QC review.
138p-hconductivity-water-quality-checkerp hconductivity waterDeterministic QC check from CSV input with JSON output for QA/QC review.
139package-integrity-leak-test-quality-checkerpackage integrity leak testDeterministic QC check from CSV input with JSON output for QA/QC review.
140paracetamol-impurity-checkerparacetamol impurity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
141particle-count-injection-usp788-quality-checkerparticle count injection usp788Deterministic QC check from CSV input with JSON output for QA/QC review.
142polyethylene-glycol-impurity-checkerpolyethylene glycol impurity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
143polymer-id-evapolymer id evaDeterministic QC check from CSV input with JSON output for QA/QC review.
144polymer-id-polyethylenepolymer id polyethyleneDeterministic QC check from CSV input with JSON output for QA/QC review.
145polymer-id-polypropylenepolymer id polypropyleneDeterministic QC check from CSV input with JSON output for QA/QC review.
146polymorph-screening-nir-ftirpolymorph screening nir ftirDeterministic QC check from CSV input with JSON output for QA/QC review.
147polysorbate80-peroxide-checkerpolysorbate80 peroxide checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
148potentiometric-titration-quality-checkerpotentiometric titrationDeterministic QC check from CSV input with JSON output for QA/QC review.
149powder-flow-quality-checkerpowder flowDeterministic QC check from CSV input with JSON output for QA/QC review.
150preparative-lcfraction-quality-checkerpreparative lcfractionDeterministic QC check from CSV input with JSON output for QA/QC review.
151preservatives-combo-qcpreservatives combo qcDeterministic QC check from CSV input with JSON output for QA/QC review.
152process-validation-checkerprocess validation checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
153protein-concentration-uvquality-checkerprotein concentration uvquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
154pyrogen-test-rabbit-matquality-checkerpyrogen test rabbit matquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
155raman-identity-quality-checkerraman identityDeterministic QC check from CSV input with JSON output for QA/QC review.
156ranitidine-impurity-checkerranitidine impurity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
157rapid-micro-alternative-method-quality-checkerrapid micro alternative methodDeterministic QC check from CSV input with JSON output for QA/QC review.
158requirement-traceability-checkerrequirement traceability checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
159residual-solvents-gcquality-checkerresidual solvents gcquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
160ribavirin-purity-checkerribavirin purity checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
161risk-control-traceability-checkerrisk control traceability checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
162sample-prep-homogenization-quality-checkersample prep homogenizationDeterministic QC check from CSV input with JSON output for QA/QC review.
163semisolid-ivrtquality-checkersemisolid ivrtquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
164sodium-benzoate-preservative-checkersodium benzoate preservative checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
165sofosbuvir-impurity-profilersofosbuvir impurity profilerDeterministic QC check from CSV input with JSON output for QA/QC review.
166software-maintenance-impact-checkersoftware maintenance impact checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
167software-safety-class-checkersoftware safety class checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
168specified-microorganisms-quality-checkerspecified microorganismsDeterministic QC check from CSV input with JSON output for QA/QC review.
169sprbinding-affinity-quality-checkersprbinding affinityDeterministic QC check from CSV input with JSON output for QA/QC review.
170stability-condition-monitoring-quality-checkerstability condition monitoringDeterministic QC check from CSV input with JSON output for QA/QC review.
171stability-shelf-life-predictorstability shelf life predictorDeterministic QC check from CSV input with JSON output for QA/QC review.
172sterility-test-membrane-filtration-quality-checkersterility test membrane filtrationDeterministic QC check from CSV input with JSON output for QA/QC review.
173supplier-evaluation-checkersupplier evaluation checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
174system-suitability-parameters-checkersystem suitability parameters checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
175tablet-coating-uniformity-nirtablet coating uniformity nirDeterministic QC check from CSV input with JSON output for QA/QC review.
176tablet-hardness-friability-quality-checkertablet hardness friabilityDeterministic QC check from CSV input with JSON output for QA/QC review.
177thermal-analysis-dsc-tgaquality-checkerthermal analysis dsc tgaquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
178tocwater-quality-checkertocwaterDeterministic QC check from CSV input with JSON output for QA/QC review.
179uvvis-identity-assay-quality-checkeruvvis identity assayDeterministic QC check from CSV input with JSON output for QA/QC review.
180viscosity-rheology-quality-checkerviscosity rheologyDeterministic QC check from CSV input with JSON output for QA/QC review.
181vitamin-aquantifiervitamin aquantifierDeterministic QC check from CSV input with JSON output for QA/QC review.
182vitamin-d3-quantifiervitamin d3 quantifierDeterministic QC check from CSV input with JSON output for QA/QC review.
183vitamin-equantifiervitamin equantifierDeterministic QC check from CSV input with JSON output for QA/QC review.
184water-activity-quality-checkerwater activityDeterministic QC check from CSV input with JSON output for QA/QC review.
185water-content-kfquality-checkerwater content kfquality checkerDeterministic QC check from CSV input with JSON output for QA/QC review.
186water-microbiology-quality-checkerwater microbiologyDeterministic QC check from CSV input with JSON output for QA/QC review.
187weight-variation-tablet-capsule-quality-checkerweight variation tablet capsuleDeterministic QC check from CSV input with JSON output for QA/QC review.
188xrpdpolymorph-quality-checkerxrpdpolymorphDeterministic QC check from CSV input with JSON output for QA/QC review.
mapping recommendation-system API Instrumental Lumex LabEx Medical Devices manufacturing QC