EN
PLContext:
A validation specialist in a pharmaceutical company performs process validation for a new medicinal product as part of the formal process validation lifecycle. In accordance with FDA and EMA regulatory requirements, the specialist must statistically demonstrate that the manufacturing process consistently produces product that meets quality specifications across multiple validation batches. Validation specialists spend considerable time on repetitive tasks such as copying data, formatting spreadsheets, creating charts, and performing statistical calculations using error-prone manual procedures.
Purpose:
The purpose of using the StatSoft PV application is to efficiently and reliably demonstrate, through comprehensive statistical analysis, that the manufacturing process consistently produces product meeting quality specifications, and to automatically generate a complete, audit-ready statistical report compliant with regulatory expectations.
Application
The QC or Manufacturing department collects validation batch data and stores it in Statistica, Excel spreadsheets or—preferably—in the dedicated StatSoft PV-DB database. Data from three consecutive validation batches are imported into StatSoft PV directly from the available sources, eliminating manual data consolidation and formatting.
The validation specialist selects the appropriate statistical methods from preconfigured templates, including: descriptive statistics, control charts and process capability indices to assess within-batch uniformity, equivalence tests to statistically confirm process repeatability.
The application automatically generates a complete, standardised, professionally formatted statistical report containing all required analyses. The validation specialist reviews the automatically generated report, adds product-specific context, investigation summaries or recommendations, and finalises the document for QA approval.
Outcome:
Using StatSoft PV, the validation specialist completed the statistical evaluation of critical process parameters, assessing within-batch uniformity using a control chart, process capability using a capability plot and indices, and process repeatability illustrated with an Out-of-Specification (OOS) probability plot.
Benefits:
Time Efficiency: Statistical reports for validation batches evaluation prepared in minutes instead of hours, significantly reducing manual effort.
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 reducing QA review cycles.
Strategic value: Focusing on scientific interpretation and process understanding rather than manual documentation.