Data integrity and data governance : practical implementation in regulated laboratories /: practical implementation in regulated laboratories. (2018)

• Record Type: Book
• Further Information: Note: R.D. McDowall.
• Authors: McDowall, R. D
• Contents: Preface; Glossary, Abbreviations and Data Integrity Terms;How to Use This Book and an Introduction to Data Integrity; How Did We Get Here?; The Regulators' Responses; What Is Data Governance?; A Data Integrity Model; Roles and Responsibilities in a Data Governance Programme; Data Integrity Policies, Procedures and Training; Establishing and Maintaining an Open Culture for Data Integrity; An Analytical Data Life Cycle; Assessment and Remediation of Laboratory Processes and Systems; Data Integrity and Paper Records; Blank Forms and Instrument Log Books; The Hybrid System Problem; Get Rid of Paper: Why Electronic Processes are Better for Data Integrity; Data Integrity Centric Analytical Instrument Qualification and Computerised System Validation; Validating Analytical Procedures; Performing an Analysis; Second Person Review; Record Retention; Quality Metrics for Data Integrity; Raising Data Integrity Concerns; Quality Assurance Oversight for Data Integrity; How to Conduct a Data Integrity Investigation; Data Integrity and Outsourcing; Data Integrity Audit Aide Memoire; Subject Index
• Edition: 1st
• Publisher Details: Cambridge : Royal Society of Chemistry
• Publication Date: 2018
• Extent: 1 online resource
• Subjects: 001.40285; Laboratories -- Data processing; Database management
• Languages: English
• ISBNs: 9781788013277; 9781788016629
• Related ISBNs: 9781788012812
• Notes: Note: Description based on CIP data; resource not viewed.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.