ProControl^®-AtOnce - Applied Statistics for Laboratories and Industries

ProControl provides statistical characteristics of measured data quick and easy. The
objectives are validation, calibration, collaboratory studies, trend analysis and forecast including uncertainty, control charts and capability studies - just to mention some features.
ProControl is based on standard Excel spreadsheets and supports full access to all excel features. ProControl is compatible to all current Excel versions.

Evaluations - an Extract in brief
Results as spreadsheet calculation or by mouse click and user guidance.

• General Statistics, DIN 53 804 T1
• Add-On Control Charts, DIN 55 303 T2
• Outlier Tests: Grubbs's- and Kurtosis tess, DIN 53 804 T1
• Homogeneity of Variances F-test, Bartlett-test, Cochran's Test
• Tests for Mean Values, ANOVA, t-Test (for homogeneous variances approved/rejected), Grubbs's tests for 'single' and 'paired' mean values, ISO 5725
• Testing the Normal Distribution, normal probability plot; DIN 53 804 T1;
• Calibration Function, DIN 32645, DIN 38402 T51
• Calibration Outliers, F-test acc. to DEV, recommended for testing water, wastewater and sludge, Outlier Tests for Residuals
• Correlation- & Trend Analysis - lin. regression up to the 4th order, optional weighting
• Method Characteristics, method standard deviation, LOD, LLOQ, LOQ
• Stability Study, shelf life to meet USL/LSL
• Setting Specification Limits which meet a required stability
• Verifying Minimum Dissolution of measured dissolution profile
• Analytical results incl. Uncertainty in Measurements, even applies for spiking results

• Add-Ons for control-charts, x ,s-charts; x,MR(2)-charts, Shewhart and approval charts, SPC, uncertainty in measurement and process capability studies ISO 3951, ISO 16949.

Higlights - ProControl^® worldwide unique features
Evaluating Shelf Life to meet USL/LSL or USL/LSL to meet Shelf Life
Facing a trend in stabilty studies the center of focus should be:

• How long will it take to reach specified limits?
• What results will be expected at a specified time?

For regulatory or customer's requirements or bilateral contract negotiations,
just to say in practice even much more important is:

• How long you are able to guarantee(!) to meet specified maximum/minimum limits?
• What maximum/minumum limts you are able to guanrantee(!) for a specified Point of time (shelf-life)?

„Guarantee“ means a high level of reliability for any stability statement, i.e. a confidence level of 99% and a calculable risk of 1%!

ProControl^® results are presented transparently and compliant to ICH Q1E.
Trends turning to decrease resulting in stability to be increased are recognised. Smoothing, proving and extrapolating trends with uncertainties is supported up to the 4th momentum.

Results of Spiking Method with Uncertainty
Spiking (DIN 32633) ensures trueness of analytical results even for sample matrices affecting the calibration. But the necessary extrapolation involves additional uncertainty.

• World debut - Uncertainty of measurement realistically estimated:
  ProControl^® overall uncertainty of analytical results of spiking includes the uncertainty of extrapolation. Thus, a bias - although verified - may disappear as the range of uncertainty of spiking is applied to routine calibration. Accuracy is ensured as the true value does not exceed the enlarged confidence range.

• The criterion in practice: Strategy of „minimum „combined uncertainty“ acc. to ISO GUM?
  The approach above poves valid at any combined uncertainty less or equal to the uncertainty of spiking, including „0“ in the prediction range . For sure, this option should be refrained, if the uncertainty of spiking proves less.
  Lit. Dr. St. Schömer „Calibration Characteristics and Uncertainty...“, in Dr. St. Kromidas (Hrsg.), "HPLC Made to Measure: A Practical Handbook for Optimisation“, 2006, Wiley-VCH"

For further information please visit our product website, download our product brochure or get in contact with us!