Tools & 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.

BioAssay Performance and Sample Size Calculator

BioAssay Performance, Acceptance Criteria and OOS.
File format: Excel, WinRAR

JMP Script Collection Add-In

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 Script, WinRAR

Partition of Variation (POV) with Measurement Systems Analysis (MSA)

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 Script, WinRAR

Low Level Risk Assessment - Version 12

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

Method Validation Quick Reference Guide 5.0

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

Product Development Scorecard

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 Factors

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

Accuracy to Precision Profiler

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

Drug Development Plan and Timeline

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

K Factor Calculator

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

POV Engine JMP Script

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

Root Cause Analysis CAPA Tools

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

Sample Size Calculator

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

Sniper Plot

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

Stability Study Design Evaluator

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

Quality Risk Management Templates

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