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Data integrity and data governance : practical implementation in regulated laboratories

Author: R D McDowall
Publisher: London : Royal Society of Chemistry, [2019] copyright 2019
Edition/Format:   eBook : Document : EnglishView all editions and formats
Summary:
This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
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Genre/Form: Electronic books
Additional Physical Format: Print version:
McDowall, R. D.
Data integrity and data governance.
[Place of publication not identified] : Royal Society of Chemistry, 2018
(OCoLC)1036295363
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: R D McDowall
ISBN: 9781788016629 1788016629
OCLC Number: 1076271956
Description: 1 online resource
Contents: Intro; Title; Copyright; Contents; Chapter 1 How to Use This Book and an Introduction to Data Integrity 1; 1.1 Aims and Objectives; 1.2 Structure of This Book; 1.2.1 Chapter Structure; 1.2.2 You Do Not Read the Regulations!; 1.2.3 The Regulatory Environment; 1.2.4 Data Governance; 1.2.5 Data Integrity; 1.2.6 Quality Oversight for Data Integrity; 1.3 Mapping This Book to the Data Integrity Model; 1.4 Pharmaceutical Quality System and Data Integrity; 1.4.1 Integration Within the Pharmaceutical Quality System; 1.4.2 No Chapter on Risk Management. 1.4.3 Back to the Future 1: Understanding Current in cGMP1.4.4 The European Equivalent of cGMP; 1.5 What Is Data Integrity?; 1.5.1 How Many Definitions Would You Like?; 1.5.2 What Do These Definitions Mean?; 1.5.3 ALCOA+ Criteria for Integrity of Laboratory Data; 1.6 Data Quality and Data Integrity; 1.6.1 From Sample to Reportable Result; 1.6.2 Contextual Metadata and a Reportable Result; 1.6.3 Data Integrity --
Can I Trust the Data?; 1.6.4 Data Quality --
Can I Use the Data?; 1.6.5 The Proposed FDA GLP Quality System; 1.6.6 Continual Versus Continuous Improvement. 1.7 Static Versus Dynamic Data1.8 Important Data Integrity Concepts; 1.8.1 Data Integrity Is More than Just Numbers; 1.8.2 Quality Does Not Own Quality Anymore; 1.8.3 Data Integrity Is Not Just 21 CFR 11 or Annex 11 Compliance; 1.8.4 Data Integrity Is an IT Problem; 1.8.5 Data Integrity Is a Laboratory Problem; 1.8.6 We Are Research --
Data Integrity Does Not Impact Us; 1.9 It's Déjà vu all Over Again!; References; Chapter 2 How Did We Get Here? 28; 2.1 Barr Laboratories 1993: You Cannot Test into Compliance; 2.1.1 Background to the Court Case; 2.1.2 Key Laboratory Findings from the Judgement. 2.1.3 Regulatory Response2.2 Able Laboratories 2005: You Cannot Falsify into Compliance; 2.2.1 Background to the Inspection; 2.2.2 483 Observations; 2.2.3 Regulatory Response; 2.3 Ranbaxy Warning Letters and Consent Decrees; 2.3.1 Background to the Regulatory Action; 2.3.2 Details of the 2012 Consent Decree; 2.4 Court Case for GLP Data Falsification; 2.5 Semler Research Data Falsification; 2.6 The Cost of Data Integrity Non-compliance; 2.6.1 Relative Costs of Compliance Versus Non-compliance; 2.6.2 Is It Worth It?; 2.7 A Parcel of Rogues: FDA Laboratory Data Integrity Citations. 2.7.1 Why Use Only FDA Warning Letters and 483 Observations?2.7.2 Quality Management System Failures; 2.7.3 Instrument Citations; 2.7.4 Citations for Lack of Laboratory Controls; 2.7.5 Failure to Have Complete Laboratory Records; 2.7.6 Too Much Data --
Duplicate Record Sets; 2.7.7 Industrial Scale Shredding and Discarding of GMP Documents; 2.7.8 Responses by the Regulatory Authorities; References; Chapter 3 The Regulators' Responses 47; 3.1 What Do the Regulators Want?; 3.1.1 EU Good Manufacturing Practice Chapter 1; 3.1.2 EU GMP Chapter 4 on Documentation.
Responsibility: R.D. McDowall.

Abstract:

This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.  Read more...

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The management of regulated industry needs to read all 600 pages in the book in order to set the standard for how every single person in their organization needs to work, themselves included. -- Siri Read more...

 
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