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.
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| Main Author | |
|---|---|
| Format | Electronic eBook |
| Language | English |
| Published |
Cambridge :
Royal Society of Chemistry,
2017.
|
| Edition | 2nd edition |
| Series | RSC chromatography monographs.
|
| Subjects | |
| Online Access | Full text |
| ISBN | 9781782624073 1782624074 1849736626 9781849736626 |
| Physical Description | 1 online resource (778 pages) |
Cover
| LEADER | 00000cam a2200000 i 4500 | ||
|---|---|---|---|
| 001 | kn-ocn967587896 | ||
| 003 | OCoLC | ||
| 005 | 20240717213016.0 | ||
| 006 | m o d | ||
| 007 | cr cn||||||||| | ||
| 008 | 161231s2017 enk o 000 0 eng d | ||
| 040 | |a EBLCP |b eng |e rda |e pn |c EBLCP |d OCLCO |d YDX |d UKRSC |d NOC |d OCLCF |d N$T |d LIP |d MERER |d OCLCQ |d LEAUB |d OCLCQ |d OCLCO |d OCLCQ |d OCLCO |d OCLCQ | ||
| 020 | |a 9781782624073 |q (electronic bk.) | ||
| 020 | |a 1782624074 |q (electronic bk.) | ||
| 020 | |z 1849736626 | ||
| 020 | |z 9781849736626 | ||
| 035 | |a (OCoLC)967587896 |z (OCoLC)966878383 |z (OCoLC)975425245 |z (OCoLC)975942284 |z (OCoLC)976144069 | ||
| 100 | 1 | |a McDowall, Robert, |e author. | |
| 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 | |
| 506 | |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty | ||
| 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. | ||
| 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 Knovel (All titles) | ||
| 650 | 0 | |a Chromatographic analysis. | |
| 655 | 7 | |a elektronické knihy |7 fd186907 |2 czenas | |
| 655 | 9 | |a electronic books |2 eczenas | |
| 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. | |
| 856 | 4 | 0 | |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpVCDSEDID/validation-of-chromatography?kpromoter=marc |y Full text |