Validation Management of Temperature and/or Temperature/Humidity

Validation Plan

Introduction

In general, Validation Plan is a written document that describes how validation will be conducted, including specification of tests parameters, characteristics of the validation object, equipment used, tasks to be performed, & decision points on what constitutes applicable test results.

PyroButton integrated solution products provide meaningful support for effective and efficient temperature and/or temperature/humidity validations. The integrated system includes:

1. PyroCAD computer aided design program for temperature mapping and virtual temperature measurement of closed systems, such as incubators, warehouses, refrigerators, freezers, processing, & quality control facilities. PyroCAD is able to provide:
   1. Temperature distribution of the object to be validated based on its characteristics and the temperature requirement specification (see, case studies)
   2. Optimum sensor positioning and the number of sensors needed (see, case studies)
   3. Virtual temperature measurements can be performed based on the above 1.A & 1.B (see, case studies)


2. Qualification of the sensors - meaningful qualification of the sensors include:


1. NIST referenced calibration of each sensor at least 5 points
2. Uncertainty of measurement is calculated for each data point
3. Creation of the calibration curve for the dynamic range of temperature measurement


3. Qualification of the Procedure: PyroButton-SQL/V program can integrate the information obtained by PyroCAD to set up the actual validation plan. We can define in PyroButton-SQL/V:
1. Specification of the object being validated, including:
   1. Physical dimensions
   2. Temperature/Humidity requirements
      1. Set points
      2. Warning Limits
      3. Critical Limits
   3. Temperature/humidity sensor positions
   4. Load conditions
      1. Quantity
      2. Content
      3. Temperature
   5. Events
      1. IQ-OQ-PQ
      2. Challenge (e.g., worst-case-scenario)
      3. SOP
2. Each data is corrected by the embedded calibration curve


4. Qualification of the Evaluation: EQUAL models for validation provide intuitive yet powerful reporting capability of the validation results. Key validation models:
1. Pareto diagrams can be used for worst-case-scenario evaluations
2. Control Charts can be used to evaluate the state of statistical control
3. Correlation analysis can be used to evaluate the relationship between several variables
4. Validation life cycle model supports concurrent validation & change control
5. Validation maintenance model ensures continuous compliance to regulations


5. E-learning for Competency of the Validation System: E-learning self-paced training in the use of the PyroButton-SQL/V validation is available on-line, desktop, or network versions. The training package provides step-by-step simulation of the validation plan, validation procedure, & validation evaluation.

• Introduction
• Vendor Suitability Analysis
• PyroButton Validation Management Model
• PyroButton-SQL/V for Optimal Validation Management of Temperature and/or Temperature/Humidity
• Validation Case Studies
• Return-On-Purchase-Investment (ROPI)
• Components of the PyroButton System
• PyroButton-Basics
• PyroButton-Standard
• PyroButton-SQL/V
• DQ-IQ-OQ-PQ
• Buy
• Learn online
• FAQ
• Technical Support