| Description |
1 online resource |
| Physical Medium |
polychrome |
| Description |
text file |
| Bibliography |
Includes bibliographical references and index. |
| 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. |
| 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. |
| Local Note |
eBooks on EBSCOhost EBSCO eBook Subscription Academic Collection - North America |
| Subject |
Laboratories -- Data processing.
|
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Laboratories -- Data processing. |
|
Laboratories. |
|
Database management.
|
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Database management. |
| Genre/Form |
Electronic books.
|
| Other Form: |
Print version: McDowall, R. D. Data integrity and data governance. [Place of publication not identified] : Royal Society of Chemistry, 2018 178801281X (OCoLC)1036295363 |
| ISBN |
9781788016629 (electronic book) |
|
1788016629 (electronic book) |
|
178801281X |
|
9781788012812 |
|
