Cleaning Validation Functions for Pharmaceutical Cleaning Process


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Documentation for package ‘CleaningValidation’ version 1.0

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CleaningValidation Cleaning Validation Package
CV Cleaning Validation Package
cv01_dfclean Clean and preprocess residue data for stability and capability analysis
cv02_nonpro_oos_reswab Summarize Non-Process Related OOS and Reswab Data Which May Not Be Included in the Analysis
cv03_usl_unification Unify USL Percentages for Specified Residue
cv04_histogram_kde Plot Histogram with Kernel Density Estimate Curve
cv05_sw_norm_test_1 Perform Shapiro-Wilk Normality Test
cv06_sw_norm_test_2 Perform Shapiro-Wilk Normality Test on Two Variables
cv071_median_control_chart Median Control Chart
cv07_median_control_chart Median Control Chart and Density Plot
cv08_variability_chart Variability Chart for Cleaning Events
cv09_kw_test Kruskal-Wallis Test for Residue Percentages
cv10_dunn_test_vs_control Dunn's Test for Residue
cv11_vca_by_median Variability Components Analysis by Median with Bootstrap
cv12_kde_ppu Calculate PPU using KDE density estimation
cv13_poisson_test Poisson Goodness-of-Fit Test
cv14_dispersion_test Dispersion Test for Poisson Regression Models
cv15_mic_mutate Calculate Mic Statistics
cv16_u_chart Create a u-Chart for Poisson-distributed Data
cv17_cusum Create a CUSUM Chart for Poisson-distributed Data
cv18_ewma Exponentially Weighted Moving Average (EWMA) Chart
cv19_poisson_simple Poisson Fixed Effect Model Summary
cv20_poisson_fixed Poisson Fixed Effect Model
cv21_poisson_mixed Poisson Mixed Effect Model Summary
cv22_var_random_effect Extract Variance of Random Effects
cv23_random_effect_coef Extract Random Effect Coefficients
cv24_vca_mic Variance Component Analysis for Microbial Counts
cv25_qbinom_ppu Binomial Process Performance Calculation
cv26_qpoisson_ppu Calculate Process Performance Index using Poisson Distribution
cv27_anscombe_ppu Process Performance Calculation using Anscombe's Transformation
cv28_freeman_ppu Calculate Ppu using Freeman's Transformation
cv29_mic_ppu Calculate Mic Ppu with Five Methods
cv30_dar_car_mic_ppu Calculate DAR, CAR, and Mic Ppu Values and Identify the Overall Minimum
Eq_CAR Equipment Cleaning Data for CAR
Eq_DAR Equipment Cleaning Data for DAR
Eq_Mic Equipment Cleaning Data for Microbial Bioburden