Robert D McDowall

Validation of Chromatography Data Systems (eBook, ePUB)

Ensuring Data Integrity, Meeting Business and Regulatory Requirements

• Format: ePub

Produktbeschreibung

Guiding chromatographers working in regulated industries and helping to validate their chromatography data systems, this book will be a detailed look at the requirements to ensure a system is fit for purpose throughout the life cycle.

---

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, D ausgeliefert werden.

Produktdetails

• Verlag: RSC
• Erscheinungstermin: 23. November 2016
• Englisch
• ISBN-13: 9781782629801
• Artikelnr.: 74745965

Inhaltsangabe

How To Use This Book
What is a CDS and its Evolution
Laboratory Informatics and the Role of a CDS
Applicable GXP Regulations and Guidance
Concepts of Computer Validation
Understanding Life Cycles and SW Classification
CDS Data Integrity
CSV Risk Management: System Risk
Working Electronically
Specifying User and System Requirements
Controlling the Validation
System Selection
Auditing the Supplier
Negotiating the Contract and System Purchase
Planning the Installation
CSV Risk Management
Importance of the Traceability Matrix
Writing the Configuration Specification
Writing the Technical Specification
Installing and Integrating System Components
Designing the Test Suite
Writing Test Cases
Executing Test Scripts
User Training and System Documentation
IT Support
System Description
Defining CDS Raw Data and E-Records
Validation Summary Report
Integration in a Regulated Environment
User Account Management
Incident and Problem Management
Change Control and Configuration Management
On-Going IT Support
Conducting a Periodic Review
CDS Records Retention
System Retirement
Data Migration Options
Retrospective Validation