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OverviewData integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few. Full Product DetailsAuthor: Orlando LópezPublisher: Taylor & Francis Ltd Imprint: CRC Press Weight: 0.580kg ISBN: 9780367616038ISBN 10: 0367616033 Pages: 320 Publication Date: 22 December 2020 Audience: Professional and scholarly , Professional & Vocational Format: Paperback Publisher's Status: Active Availability: In Print  This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of Contents1 Introduction 2 E-records Lifecycle Revisited 3 Data and E-records Lifecycles – A Comparison 4 MHRA Guidance – Revisited 5 E-records Integrity Expectations of EU GMP Inspectors 6 Comparison of Health Authorities E-records Integrity Expectations 7 Maxims of E-records Integrity 8 Vulnerabilities of E-records 9 CGMP E-records Risk Management 10 CGMP E-records Risk Assessments 11 Security Service 12 Defining and Managing Manufacturing Data 13 Controls on Transient Data 14 Digital Date and Timestamps 15 E-records Migration and Its Integrity 16 Ensuring E-records Integrity of Cloud Service Providers 17 E-records Integrity in Hybrid Systems 18 Technologies Supporting E-records Integrity 19 Integration Between Computer Systems and E-records Lifecycles 20 Miscellaneous E-records Integrity Issues 21 E-records Remediation Project Revisited – Medicine Manufacturing 22 Designing E-records Integrity into your Practices 23 Introduction to Data Quality 24 SummaryReviewsAuthor InformationOrlando Lopez has significant understanding and experience with worldwide regulatory authorities regarding CSV, e-records integrity, and related requirements/guidelines related to Production Manufacturing Systems, IT Systems, Analytics, and Business Intelligence. He has knowledge and experience in the development of governance and SLC deliverables. Wrote and deployed CSV methodology to computer infrastructure J&J worldwide. Several times he had re-engineered the computer validation methodology to regulated companies. Orlando Lopez has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications. He is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation and has written 25+ publications, including 9 computer compliance related books - amazon.com/author/orlandolopez/ Familiar with gap assessment, remediation planning and remediation execution activities. Tab Content 6Author Website:Countries AvailableAll regions |
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