AnalyticaQC
Analytical QC Intelligence
For pharmaceutical QC laboratories

Turn Analytical QC Work Into a Guided, Data-Driven Workflow

Calculate. Validate. Investigate. Trend. Improve.

AnalyticaQC guides an analyst from method and study design through preparation, experiment, data, calculation, statistics and assessment to a draft report — with deterministic calculations, configurable acceptance criteria and a full audit trail.

Decision-support only. No result is GMP-approved by the system; acceptance criteria are configured by the laboratory and every assessment requires qualified human review.

Validation project · VAL-2026-014
HPLC Assay — Atorvastatin Tablets 20 mg
  • SpecificityComplete
  • LinearityComplete
  • AccuracyComplete
  • RepeatabilityComplete
  • LOQIn progress
  • RobustnessNot started
y = 19,950·x + 4,120 · r² = 0.9998 · max dev. 0.8 %

Demo data — not for GMP use.

One platform across the analytical lifecycle

Each module writes to the same project data model, so calculations, graphs, reports and the audit trail always reflect the same underlying results.

Analytical Calculations

Concentration, dilution, potency correction, assay, related substances, dissolution, content uniformity — every result shown as inputs → formula → calculation.

Method Validation

Guided validation projects with a parameter engine that proposes a study design you can modify, not impose.

Method Verification

A distinct compendial verification workflow — never silently treated as a full validation.

LOD / LOQ

σ/slope and S/N approaches, LOQ preparation instructions, replicate verification and suitability assessment.

Linearity & Range

Regression, residuals, back-calculated concentrations and deviation from nominal — never r² alone.

Accuracy & Precision

Recovery studies, bias, confidence intervals, repeatability and intermediate precision with ANOVA.

OOS / OOT

Structured Phase I laboratory investigation checklists with escalation guidance — results are never invalidated automatically.

Stability Trending

Time-series attribute trending with specification, alert and action limits and batch comparison.

QC Copilot

Context-aware analytical assistant that labels every statement as fact, calculation, interpretation or recommendation.

Audit-Ready Documentation

Draft protocols and reports built from your stored project data, with a complete action-level audit trail.

Transparent by design

Formulas, intermediate steps and units are always displayed. Nothing is rounded away silently.

Criteria are configured, never invented

Every assessment states the configured source, version and approver behind the criterion.

Traceable end to end

Calculations, data entry and reviews are recorded with user, timestamp and previous value.