Validation of Computerized Analytical Systems

✍ Scribed by Ludwig Huber

• Tongue: English
• Leaves: 265
• Category: Library

✦ Synopsis

Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details.International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.

✦ Table of Contents

Cover
Title
Copyright
Preface
Contents
1. Introduction
2. Regulations and Quality Standards
(Current) Good Manufacturing Practice (cGMP) Regulations
Good Laboratory Practice (GLP) Regulations
Good Clinical Practice (GCP) Regulations
Good Automated Laboratory Practice (GALP)
Quality Standards and Guidelines
EN 45000 Series and ISO/IEC Guide 25
NAMAS Accreditation Standard
ISO 9000 Series of Quality Standards and ISO 9000-3
TickIT
3. Definitions: Computer Systems, Computerized Systems and Software
4. Validation Processes in the Analytical Laboratory
Definitions of Validation
Validation vs. Verification, Testing, Calibration and Qualification
Testing
Verification
Calibration
Qualification
Validation
Validation Steps in the Laboratory
5. Life Cycle Approach for Validation of Software and Computer Systems
Validation of New Systems During Development
Evaluation of Existing Systems (Retrospective Validation) at the User's Site
Validation of 'Office Programs' Used for Laboratory Applications
Revalidation and Reverification of Software and Computerized Systems
When Is Reverification and Revalidation Required?
What Should Be Revalidated?
How Should Test Files Be Reused?
6. Validation Efforts at the Vendor's Site
Requirements Analysis and Definition Phase
Design Phase
Implementation Phase
Test Phase
Types of Testing
Alpha-Testing
Beta-Testing
Defect Tracking and Response System
Release for Production and Installation
Operation and Maintenance
Change Control
Documentation
7. Responsibilities of Vendors and Users
Software Categories
Validation Responsibilities
Source Code Availability
Vendor Testing and Specifications
User Testing
Support
Combined Standard and User Contributed Software
8. Calibration, Verification and Validation of Equipment
Validation/Verification at the Vendor's Site
Activities at the User's Site
9. Selection and Qualification of a Vendor
Selecting a Vendor
How Well Do They Know Good Practice Regulations and Quality Standards?
Will They Allow an Audit?
Do They Provide Adequate Long-Term Support?
Do They Build All the Required Functions into the Product?
Do They Supply Source Code to Regulatory Agencies?
Do They Supply Details of Algorithms?
Do They Have an Adequate Quality System?
Will They Asist with On-Site Validation?
Vendor Qualification
10. Installation and Operation
Preparing for Installation
Installation
Logbook
Operator Training
Preparing for Operation
Operation
11. Validation of Analytical Methods
Strategies for Method Validation
Parameters for Method Validation
Selectivity
Precision and Reproducibility
Accuracy
Linearity
Range
Limit of Detection and Quantitation
Stability
Ruggedness
12. Maintenance and Ongoing Performance Control
Maintenance
Calibration and Performance Verification
Calibration
Performance Verification (PV)
System Suitability Testing and Analytical Quality Control (AQC)
System Suitability Testing
Quality Control (QC) Samples with QC Charts
Handling of Defective Instruments
13. Testing of Chromatographic Computer Systems
Examples for Specifications and Tests for a Computerized HPLC System
Specifications
Modular Functional Testing
Integrated System Testing
Verification of Peak Integration
Automated Procedure for Testing a Chromatographic Computer System
14. Data Validation, Audit Trail, Security and Traceability
Data Entry
Manual Data Entry
Tracking Equipment and People
Raw Data: Definition, Processing and Archiving
Definition of Raw Data
Defining and Archiving Chromatographic Raw Data
Audit Trail for Amended Data
Validation of Data
Security and Integrity of Data and Back-up
Security
Back-up and Recovery
Security Features Built into the Computer System
15. Diagnostics, Error Recording and Reporting
16. Audit/Inspection of Computerized Systems
Appendix A. Glossary
Appendix B. (Standard) Operating Procedures
Example #1: Development and Validation of Simple Application Software
Example #2: Development and Validation of a Complex Application Software
Example #3: Testing Precision of Peak Retention Times and Areas of an HPLC System
Example #4: Retrospective Evaluation and Validation of Existing Computerized Analytical Systems
Appendix C. Strategy for Chronological Selection and Validation of Computerized Analytical Systems
Appendix D. Testing of Selected Equipment
High-Performance Liquid Chromatography
Precision of Retention Times and Peak Areas
Baseline Noise of Systems with UV-visible Detectors
Signal to Noise of Systems with Non UV-visible Detectors
Limit of Detection
Limit of Quantitation
Linearity
Wavelength Accuracy of UV-visible Detectors
Carry Over
Flow Rate Accuracy
Composition Accuracy
Pressure Test
Capillary Electrophoresis (CE)
Migration Time Precision
Peak Area Precision
Carry Over
Detector Baseline Noise
Wavelength Accuracy
Detector Linearity
Injection Linearity
Gas Chromatography
Precision of Retention Times and Peak Areas
Signal to Noise of Detectors
Linearity
Oven Temperature Accuracy
References
Indexes
Name Index
Subject Index