EN
PLContext
A Quality Control (QC) analyst in a pharmaceutical company performs validation of an analytical method used to determine the active substance content in the finished product. In accordance with ICH Q2(R2), FDA and EMA requirements, the analyst must demonstrate that the method is fit for its intended purpose by assessing performance characteristics such as accuracy, precision, calibration parameters, limit of detection (LOD), and limit of quantification (LOQ). Manual data processing is time-consuming and prone to errors, increasing the risk of non-compliance with regulatory expectations.
Purpose
The purpose of using the StatSoft AMV application is to enable efficient and reliable statistical analyses for validation characteristics and to generate complete validation reports that meet regulatory requirements.
Application
The QC analyst starts by creating a new validation project in the StatSoft AMV application, defining the study context, performance characteristics, acceptance criteria, and the experimental design. Raw data for each characteristic (accuracy, precision, calibration parameters, LOD and LOQ) are then imported from pre-prepared Excel or Statistica files.
Depending on the characteristic being evaluated, the analyst selects the appropriate statistical procedures from preconfigured templates. StatSoft AMV automatically performs all required calculations, compares the results with predefined acceptance criteria, and generates a complete, professionally formatted validation report for each characteristic
Finally, the QC analyst reviews the automatically generated report for completeness and consistency, adding method-specific interpretations and any additional contextual information as needed.
Outcome:
Using StatSoft AMV the QC analyst completed the task performing statistical assessment for all performance characteristics (accuracy, precision, model calibration) required by ICH Q2(R2).
Benefits:
Time Efficiency: Statistical reports for analytical method validation prepared in minutes instead of hours.
Regulatory Compliance: Comprehensive, audit-ready documentation with lower risk of regulatory observations related to inadequate statistical analysis.
Data-Driven Decisions: Evidence-based recommendations supported by robust statistical analysis.
Consistency: Standardized reporting format, pre-validated statistical methods and report templates.
Strategic value: Reduced regulatory submission/inspection risk through validated, defensible statistical analysis.