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Validation of Computerized Analytical and Networked Systems

Validation of Computerized Analytical and Networked Systems

          
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About the Book

From the author of the best-selling Validation of Computerized Analytical Systems, this book provides the latest information to guide you through the entire validation process, from writing a validation plan through implementation, testing, and installation qualification, to ongoing calibration, performance qualification, and change control. This book is all you need to perform computer systems validation cost-effectively and in a manner acceptable to national and international regulatory agencies (FDA GCP/GLP/GMP/GALP/GAMP, ISO/IEC 17025, NAMAS). Validation of Computerized Analytical and Networked Systems includes an up-to-the-minute discussion of 21 CFR Part 11-Electronic Records; Electronic Signatures, as well as a chapter on bringing legacy systems into compliance with 21 CFR Part 11 regulations.

Table of Contents:
Introduction

REGULATIONS AND STANDARDS
(Current) Good Manufacturing Practice (cGMP) Regulations
Good Laboratory Practice (GLP) Regulations
Good Clinical Practice (GCP) Regulations
Good Automated Laboratory Practices (GALP)
Electronic Records and Signatures
Quality Standards and Guidelines

TERMINOLOGY
Definition and Elements of Validation
Validation versus Verification and Qualification
Computer Systems and Computerized Systems
Software Categories
CAMP Categories
Validation Processes in a Laboratory
Validation Time Line
Validation Strategy or Policy
Validation Team Steering Committee
Individual Validation Project Teams
Company Validation Master Plan
Individual Project Validation Plans
Summary Recommendation for Validation Planning and Implementation

DESIGN QUALIFICATION
Recommended Steps in Design Qualification
User Requirement Specifications
Functional Specifications
Selected Examples

VENDOR ASSESSMENT
Vendor Assessment Levels
Criteria and Recommendations for Vendor Audits

VALIDATION DURING DEVELOPMENT
Development and Validation Overview
Checkpoint Meetings
Setting User Requirements and Functional Specifications
Design Phrase
Implementation Phase
Testing
Release for Production and Installation
Operation and Maintenance
Change Control
Documentation

INSTALLATION QUALIFICATION
Preparing for Installation
Installation
Logbook
Operator Training
Documentation

OPERATIONAL QUALIFICATION
Selecting Tests Based on Risk Assessment
Performing and Documenting Tests
Example for Integrated System Testing
Defining Data Files and Test Routines for Reuse
Tests of Multiple Computer Systems
Requalification
Documentation

MAINTENANCE AND ONGOING PERFORMANCE QUALIFICATION
Preventative Maintenance
Virus Checks
Data Backup and Archiving
Disaster Recovery
Ongoing Performance Testing
Change Control
Documentation

VALIDATION OF MACROS AND SPREADSHEET PROGRAMS
What Should Be Validated?
Planning and Setting Specifications
Designing the Program
Developing the Code
Testing
Using Spreadsheets and Macros
Documentation

VALIDATION OF NETWORKED SYSTEMS
Definitions
FDA Findings and Expectations
Systems and Tasks to Be Qualified and Validated
Examples of Networked Systems
The Qualification/Validation Approach Using the 4Q Model
Validation Master Plan and Validation Team
Setting Specifications (URS, FS)
Installation
Testing
Data Backup, Recovery, and Contingency Planning
Change Control and Maintaining Security
Documentation
Implementation Summary

COMPLIANCE WITH ELECTRONIC RECORDS AND SIGNATURES (21 CFR PART 11)
Development and Current Status of the Rule
Terminology
Scope of Part 11 for Chromatographic Systems
Workflow in Computerized Analytical Instruments
Electronic Records in Chromatography
Requirements of 21 CFR Part 11
Summary Recommendations for Implementation

OPERATIONAL COMPLIANCE OF LEGACY SYSTEMS
Regulatory Requirements, Inspection Findings, FDA's Enforcement Practices
Compliance Policy and Master Plan
Administrative Controls
System Inventory, Gap and Risk Analysis
Cost Analysis
Implementation Plan
Retrospective Evaluation
Specific Characteristics of Older Systems
Procedure for Retrospective Evaluation

AUDITS
Audit Findings
Planning, Implementation, and Reporting Internal Audits
Audit Evaluation and Reports

Appendix A: Glossary
Appendix B: Standard Operating Procedures
Appendix C: Literature Cited

Index


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Product Details
  • ISBN-13: 9781574911336
  • Publisher: Taylor & Francis Inc
  • Publisher Imprint: CRC Press Inc
  • Height: 254 mm
  • No of Pages: 240
  • Weight: 544 gr
  • ISBN-10: 1574911333
  • Publisher Date: 01 Oct 2001
  • Binding: Hardback
  • Language: English
  • Returnable: N
  • Width: 178 mm


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