Data Integrity in the Chromatography Laboratory, Part V: Second-Person Review

被引：0

作者：

Newton, Mark E. ^{[1
]}

McDowall, R. D. ^{[2
]}

机构：

[1] Heartland QA, Lebanon, IN USA

[2] RD McDowall Ltd, Bromley, Kent, England

来源：

LC GC NORTH AMERICA | 2018年 / 36卷 / 08期

关键词：

D O I：

暂无

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

The fifth article in this series discusses the second-person review process for regulated records and the risks to be addressed, such as reviewing all data in the run, including aborted or rejected data. The added review costs (and time) of hybrid records and paper logbooks are illustrated. Common failure modes for review are identified. Finally, some management behaviors that compound an already complex step are described along with their consequences.

引用

页码：527 / 531

页数：5

共 19 条

[1] THE 'RIMA V' OF BECQUER IN THE SECOND-PERSON
SEBOLD, RP
BOLETIN DE LA REAL ACADEMIA ESPANOLA, 1995, 75 (264): : 7 - 23
[2] Data Integrity in the GxP Chromatography Laboratory, Part III: Integration and Interpretation of Data
Newton, Mark E.
McDowell, R. D.
LC GC NORTH AMERICA, 2018, 36 (05) : 330 - 335
[3] Data Integrity in the GXP Chromatography Laboratory, Part IV: Calculation of the Reportable Results
Newton, Mark E.
McDowell, R. D.
LC GC NORTH AMERICA, 2018, 36 (07) : 458 - 462
[4] Data Integrity in the GxP Chromatography Laboratory, Part I: Sampling and Sample Preparation
Newton, Mark E.
McDowall, R. D.
LC GC NORTH AMERICA, 2018, 36 (01) : 46 - 51
[5] Data Integrity in the GxP Chromatography Laboratory, Part II: Setting up a Chromatograph and Acquiring Data
Newton, Mark E.
McDowell, R. D.
LC GC NORTH AMERICA, 2018, 36 (04) : 270 - 274
[6] Data Integrity in the Chromatography Laboratory, Part VI: Open Culture, Training, and Monitoring Metrics
Newton, Mark E.
McDowall, R. D.
LC GC NORTH AMERICA, 2018, 36 (09) : 686 - 689
[7] Data Integrity Focus, Part IX: Understanding Data Integrity Metrics for Chromatography
McDowall, R. D.
LC GC NORTH AMERICA, 2019, 37 (10) : 762 - 766
[8] Data Integrity Focus, Part VII: A Data Life Cycle for Chromatography
McDowall, R. D.
LC GC NORTH AMERICA, 2019, 37 (08) : 532 - 537
[9] The Ideal Chromatography Data System for a Regulated Laboratory, Part IV: Ensuring Regulatory Compliance
Archambault, Lynn
Bush, Laura
LC GC NORTH AMERICA, 2016, 34 (02) : 144 - 149
[10] The Ideal Chromatography Data System for a Regulated Laboratory, Part I: The Compliant Analytical Process
McDowall, R. D.
Burgess, Chris
LC GC NORTH AMERICA, 2015, 33 (08) : 554 - 557

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