| 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: | |
| 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
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