Validation of Chromatography Data Systems 2nd Edition (PDF)

Validation of Chromatography Data Systems

Author:
R. D. Mc Dowall
Release at: 2017
Pages: 776
Edition:
2nd Edition (Ensuring Data Integrity, Meeting Business and Regulatory Requirements)
File Size: 16 MB
File Type: pdf
Language: English



Description of Validation of Chromatography Data Systems 2nd Edition (PDF)

Validation of Chromatography Data Systems 2nd Edition by R. D. Mc Dowall is a great Chromatography book for Chemistry students available for (PDF) download. Why read or even buy this Why read or even buy this book? If you are using this Validation of Chromatography Data Systems book in the regulated areas of the pharmaceutical, medical device, active pharmaceutical ingredient, and contract research organizations, you will need to validate the system. This Validation of Chromatography Data Systems book will be your guide through the regulations and jargon.

This Validation of Chromatography Data Systems book provides practical advice that can be used directly by you to meet regulatory requirements and allow a sustainable validation effort for your chromatography data system throughout its operational life. book? If you are using this Validation of Chromatography Data Systems book in the regulated areas of the pharmaceutical, medical device, active pharmaceutical ingredient, and contract research organizations, you will need to validate the system.

This Validation of Chromatography Data Systems book will be your guide through the regulations and jargon. This Validation of Chromatography Data Systems book provides practical advice that can be used directly by you to meet regulatory requirements and allow a sustainable validation effort for your chromatography data system throughout its operational life.

The importance of validation of laboratory computerized systems operating in regulated laboratories has not changed and is indeed become more important since the publication of the first edition of this book. Since 2005, there has been a detection of increased fraud and falsification involving chromatography data systems, as evidenced in FDA warning letters and citations by other regulatory authorities.

Coupled with this, are poor data management practices that have also resulted in increased regulatory scrutiny of these systems as often chromatographic analysis can constitute up to 100% of a GXP regulated laboratory’s workload. This results in the detailed examination of the system: the validation, change control as well as the integrity of the electronic records/raw data generated.




Content of Validation of Chromatography Data Systems 2nd Edition (PDF)


Chapter 1: How to Use this Book

Chapter 2: What is a CDS? The Past, Present and Future

Chapter 3: Laboratory Informatics and the Role of a CDS

Chapter 4: Application GXP Regulations and Guidance for CSV

Chapter 5: Concepts of Computer Validation

Chapter 6: Understanding Software Categories and System Life Cycles

Chapter 7: Ensuring Data Integrity for Chromatography Data Systems

Chapter 8: CDS VAlidation: Managing System Risk

Chapter 9: Working Electronically and Using Electeonic Signatures

Chapter 10: Writing the User and System Requirements

Chapter 11: Controlling the Validation

Chapter 12: System Selection

Chapter 13: Assessing the CDS Supplier

Chapter 14: Negotiating the Contract and Purchasing the System

Chapter 15: Planning the Installation of the System

Chapter 16: CSV Risk Management Requirements Level Assessment

Chapter 17: Importance of the Traceability Matrix

Chapter 18: Writing Configuration Specifications

Chapter 19: Writing the Techical Specification

Chapter 20: Installing and Integrating System Components

Chapter 21: Designing the User Acceptance Test Suite

Chapter 22: Writing Test Scripts and Test Cases

Chapter 23: Executing Test Scripts and Reporting the Results

Chapter 24: User Training and System Documentation

Chapter 25: IT Support for a CDS

Chapter 26: System Description

Chapter 27: Defininig Electronic Records and Raw Data for a CDS

Chapter 28: Writing the Validation Summary Report

Chapter 29: Integration in a Regulated Environment

Chapter 30: User Account Management

Chapter 31: Incident and Problem Management

Chapter 32: Change Control and Configuration Management

Chapter 33: Periodic Review of the CDS

Chapter 34: CDS Records Retention

Chapter 35: CDS System Retirement

Chapter 36: CDS Data Migration

Chapter 37: Retrospective Validation

Glossary and Abbreviations

Index

GET THIS BOOK

Also Available

Current Trends in the Embryology of Angiosperms by S.S. Bhojwani & W.Y. Soh
GET THIS BOOK

Plant Anatomy An Applied Approach by David F Cutler, Ted Botha & D.W. Stevenson
GET THIS BOOK

Plant Pathology by R S Mehrotra and Ashok Aggarwal 3rd Edition
GET THIS BOOK

Plant Pathology The Diseased Plant by James G. Horsfall
GET THIS BOOK

Plant Pathology by George N Agrios 5th Edition
GET THIS BOOK
Similar Books

0 comments:

John Academy