General Statistics & Quality by Design Tools
Tools and Templates
The following development tools and templates have been created by Thomas A. Little Consulting and have been used by numerous companies to aid and support various aspects of product development, problem solving, data analysis and risk assessment.

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Most common scripts and templates for use with Thomas A. Little Consulting. Double click the extracted add-in file to automatically install into JMP.
File format: JMP, WinRAR

To help organize studies and perform detailed risk assessments prior to experimentation.
File format: Excel, WinRAR

K-value calulator for JMP.
File format: JMP, WinRAR

POV with MSA is a custom script that calculates components of variance for both the between group variation and the within group variation. Further, the script uses this capability to better understand the variation in a measurement system or analytical method.
File format: JMP, WinRAR

To help organize studies and perform detailed risk assessments prior to experimentation.
File format: Excel, WinRAR

This Excel based template makes it easy to know the most essential requirements and concepts from Q2 Method Validation and USP 1033.
File format: Excel, WinRAR

Development Scorecard helps development teams account for maturity of product development and the accumulated failure, defect rates and process capability.
File format: Excel, WinRAR

F2 F1 dissolution comparison is used to examine and compare the dissolution profiles of test to reference drug using FDA recommended procedures.
File format: JMP, WinRAR

Evaluate the impact of assay accuracy and precision error on out of specification rates.
File format: JMP, WinRAR

Complete systematic drug development timeline, owners and action items.
File format: Excel, WinRAR

Determine the K factor for tolerance intervals.
File format: JMP, WinRAR

Identify and quantify variation patterns in products, assays and processes.
File format: JMP, WinRAR

A general set of problem solving tools and templates.
File format: Excel, WinRAR

Determine the sample size to detect a change in performance reliably.
File format: Excel, WinRAR

Determine the target of X to achieve a target in Y.
File format: JMP, WinRAR

Evaluate sample size and study design for stability (simulation tool).
File format: JMP, WinRAR

A general set of tools for Quality Risk Management and risk assessment.
File format: JMP, WinRAR

File format: Excel, WinRAR

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