Validation of chromatography data systems /

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.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: McDowall, Robert (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Cambridge : Royal Society of Chemistry, 2017.
Edición:2nd edition
Colección:RSC chromatography monographs.
Temas:
Chromatographic analysis.
Chromatography
Chromatographie.
chromatography.
SCIENCE > Chemistry > Analytic.
Chromatographic analysis
Acceso en línea:Texto completo

MARC

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245 1 0 |a Validation of chromatography data systems /  |c Robert McDowall. 
250 |a 2nd edition 
264 1 |a Cambridge :  |b Royal Society of Chemistry,  |c 2017. 
300 |a 1 online resource (778 pages) 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
490 1 |a RSC chromatography monographs ;  |v volume 20 
520 |a 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. 
588 0 |a Print version record. 
505 0 |a Cover; Validation of Chromatography Data Systems: Ensuring Data Integrity, Meeting Business and Regulatory Requirements 2nd Edition; Preface to the First Edition; Preface to the Second Edition; Biography; Acknowledgements; Contents; Chapter 1 -- How to Use this Book; 1.1 Purpose and Scope; 1.2 The Way It Was & ; 1.3 The Way It Should Be & ; 1.4 Book Structure: Life to Death of a CDS; 1.4.1 Chapter Structure; 1.4.2 Part 1: Understanding the Basics; 1.4.3 Part 2: Planning the Work; 1.4.4 Part 3: Selecting the System; 1.4.5 Part 4: Risk, Traceability, Configuration, Installation and Integration 
505 8 |a 1.4.6 Part 5: User Acceptance Testing 1.4.7 Part 6: Supporting Documentation and System Release; 1.4.8 Part 7: Maintaining the Validation Status; 1.4.9 Part 8: Records Retention and System Retirement; 1.4.10 Part 9: When All Else Fails: Retrospective Validation of a CDS; 1.4.11 Ensuring Data Integrity; 1.4.12 Importance of the Second Person Review in Ensuring Data Integrity; 1.5 Use Your Organisation's Computer Validation Procedures; 1.5.1 Terminology Used in this Book; 1.6 Why Does it Take so Long to Validate a CDS; 1.6.1 CDS Validation: The Way It Is 
505 8 |a 1.6.2 CDS Validation: The Way It Should Be1.6.3 The Core System; 1.7 Ten Critical Success Factors for Fast CDS Validation; 1.7.1 Management Involvement and Backing; 1.7.2 Dedicated Key Project Team Members; 1.7.3 Use an Appropriate Life Cycle Model; 1.7.4 Knowledge of the CDS Application; 1.7.5 Active and Flexible Quality Assurance Involvement; 1.7.6 Effective and Compliant IT Participation; 1.7.7 Use the Supplier Effectively; 1.7.8 Planning, Planning and Planning; 1.7.9 Focus on the Core System; 1.7.10 Get More from Less Testing; 1.8 Assumptions, Exclusions and Limitations 
505 8 |a Chapter 2 -- What is a CDS The Past, Present and Future 2.1 Introduction to Chromatography Data Systems; 2.2 What is a Chromatography Data System; 2.2.1 Types of Chromatography Data System; 2.2.2 Naming Conventions; 2.2.3 Data Acquisition Files; 2.2.4 Instrument Control Files; 2.2.5 Sequence File; 2.2.6 Acquisition of Chromatographic Data; 2.2.7 Management of Data: Database or Files; 2.2.8 Interpretation of Chromatographic Data; 2.2.9 System Suitability Test (SST) Calculations; 2.2.10 Calibration; 2.2.11 User Defined Analytical Run Parameters; 2.2.12 Collation of Results and Reports 
505 8 |a 2.2.13 Architecture of a Networked Cds 2.3 Evolution of Chromatography Data Systems; 2.3.1 CDS: Where Have We Come From; 2.3.2 The Evolutionary Ages of CDS; 2.4 Stone Age: Paper Based Peak Measurement Techniques; 2.4.1 Cut and Weigh; 2.4.2 Ruler and Pencil; 2.4.3 Disk Integrator; 2.4.4 Summary of Stone Age CDS; 2.5 Bronze Age: Electronic Peak Measurement; 2.5.1 Central Data Systems; 2.5.2 Computing Integrators; 2.5.3 Summary of Bronze Age CDS; 2.6 Iron Age: Expansion to Include Instrument Control; 2.6.1 Standalone PCs: Extension to Instrument Control; 2.6.2 PC Client-Server Networks 
590 |a Knovel  |b ACADEMIC - Process Design, Control & Automation 
590 |a Knovel  |b ACADEMIC - Nondestructive Testing & Evaluation 
650 0 |a Chromatographic analysis. 
650 2 |a Chromatography 
650 6 |a Chromatographie. 
650 7 |a chromatography.  |2 aat 
650 7 |a SCIENCE  |x Chemistry  |x Analytic.  |2 bisacsh 
650 7 |a Chromatographic analysis  |2 fast 
776 0 8 |i Print version:  |a McDowall, Robert.  |t Validation of chromatography data systems.  |b 2nd edition.  |d Cambridge : Royal Society of Chemistry, 2017  |z 9781849736626 
830 0 |a RSC chromatography monographs. 
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