LabEx QC Suite

Пакет LabEx для лабораторных методов контроля качества: хроматография, спектроскопия, микробиология, стерильность, эндотоксины, частицы, растворение, вода, чистые помещения и подготовка образцов.

60 Утилиты Core QC utility packages LabEx laboratory QC instrumental methods microbiology sterility chromatography

Статья Статья

Почему выбирают FUZKK

✓ Меньше Excel-рисков

Детерминированные расчёты и проверки правил вместо неконтролируемых таблиц.

🔍 Готовность к аудиту

Готовность к аудиту (IQ/OQ): каждая утилита пакета поставляется с URS/FS, CSV-контрактом, JSON-выходом и структурой данных, пригодной для CSV/CSA, OQ/PQ и QA/QC review.

⏱ Время лаборатории

Более быстрая проверка данных, ревью партии и структурированный JSON-результат для последующих систем.

🚀 Интеграция

Подходит для CSV, LIMS/ELN/MES и валидируемых лабораторных процессов.

Схема интеграции

Instrument / LIMS / ELN / MES → input.csv → LabEx QC Suite → output.json → QA approval / audit trail

Утилиты в пакете

Утилита	API / Monograph	Категории	Теги
AssayImpurityHPLCQualityChecker	Assay & Impurity HPLC	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
AutomatedLiquidHandlingQCQualityChecker	Automated Liquid Handling QC	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
AutomatedSterilityDetectionQualityChecker	Automated Sterility Detection	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
BacterialEndotoxinsLALQualityChecker	Bacterial Endotoxins LAL	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
BacterialEndotoxinsRecombinantQualityChecker	Bacterial Endotoxins Recombinant	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
BiologicAggregateSizeQualityChecker	Biologic Aggregate Size	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
ChargeVariantCEQualityChecker	Charge Variant CE	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
ChiralPurityHPLCQualityChecker	Chiral Purity HPLC	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
CircularDichroismBiologicQualityChecker	Circular Dichroism Biologic	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
ContentUniformityQualityChecker	Content Uniformity	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
DeliveredDoseUniformityInhalerQualityChecker	Delivered Dose Uniformity Inhaler	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
DensityRefractiveIndexQualityChecker	Density & Refractive Index	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
DisintegrationTabletCapsuleQualityChecker	Disintegration Tablet/Capsule	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
DissolutionApparatus12QualityChecker	Dissolution Apparatus 1 & 2	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
DissolutionExtendedReleaseQualityChecker	Dissolution Extended Release	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
ElementalImpuritiesICPQualityChecker	Elemental Impurities ICP	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
ELISABioassayQualityChecker	ELISA Bioassay	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
EndotoxinBiologicProductQualityChecker	Endotoxin Biologic Product	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
EnvironmentalMonitoringCleanroomQualityChecker	Environmental Monitoring Cleanroom	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
FilterIntegrityTestQualityChecker	Filter Integrity Test	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
FluorescenceSpectroscopyQualityChecker	Fluorescence Spectroscopy	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
FTIRIdentityQualityChecker	FTIR Identity	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
GCMSScreeningVolatileImpuritiesQualityChecker	GC-MS Screening Volatile Impurities	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
HeavyMetalsLimitTestQualityChecker	Heavy Metals Limit Test	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
InhalationAPSDQualityChecker	Inhalation APSD	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
LCMSConfirmationQualityChecker	LC-MS Confirmation	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
LossOnDryingQualityChecker	Loss On Drying	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
MeltingPointQualityChecker	Melting Point	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
MicrobialEnumerationTAMCTYMCQualityChecker	Microbial Enumeration (TAMC/TYMC)	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
MicrobialIdentificationSystemQualityChecker	Microbial Identification System	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
MicrowaveDigestionPrepQualityChecker	Microwave Digestion Prep	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
NMRStructureQualityChecker	NMR Structure	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
OsmolalityQualityChecker	Osmolality	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
PackageIntegrityLeakTestQualityChecker	Package Integrity & Leak Test	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
ParticleCountInjectionUSP788QualityChecker	Particle Count Injection USP <788>	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
pHConductivityWaterQualityChecker	pH & Conductivity Water	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
PotentiometricTitrationQualityChecker	Potentiometric Titration	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
PowderFlowQualityChecker	Powder Flow	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
PreparativeLCFractionQualityChecker	Preparative LC Fraction	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
ProteinConcentrationUVQualityChecker	Protein Concentration UV	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
PyrogenTestRabbitMATQualityChecker	Pyrogen Test (Rabbit & MAT)	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
RamanIdentityQualityChecker	Raman Identity	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
RapidMicroAlternativeMethodQualityChecker	Rapid Micro Alternative Method	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
ResidualSolventsGCQualityChecker	Residual Solvents GC	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
SamplePrepHomogenizationQualityChecker	Sample Prep Homogenization	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
SemisolidIVRTQualityChecker	Semisolid IVRT	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
SpecifiedMicroorganismsQualityChecker	Specified Microorganisms	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
SPRBindingAffinityQualityChecker	SPR Binding Affinity	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
StabilityConditionMonitoringQualityChecker	Stability Condition Monitoring	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
SterilityTestMembraneFiltrationQualityChecker	Sterility Test Membrane Filtration	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
TabletHardnessFriabilityQualityChecker	Tablet Hardness & Friability	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
ThermalAnalysisDSC_TGAQualityChecker	Thermal Analysis DSC/TGA	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
TOCWaterQualityChecker	TOC Water	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
UVVisIdentityAssayQualityChecker	UV-Vis Identity & Assay	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
ViscosityRheologyQualityChecker	Viscosity & Rheology	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
WaterActivityQualityChecker	Water Activity	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
WaterContentKFQualityChecker	Water Content KF	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
WaterMicrobiologyQualityChecker	Water Microbiology	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
WeightVariationTabletCapsuleQualityChecker	Weight Variation Tablet/Capsule	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS
XRPDPolymorphQualityChecker	XRPD Polymorph	Laboratory QC / instrumental methods	LabEx laboratory QC CSV→JSON URS & FS

Лицензирование и поддержка

Лицензирование и поддержка: пакет поставляется как набор QC-утилит для одной компании или производственной площадки, с возможной поддержкой пилота, LIMS/ELN/MES-интеграции и подготовки к валидации.