Ensuring the Integrity of Electronic Health Records: The Best Practices for E-records Compliance
暫譯: 確保電子健康紀錄的完整性：電子紀錄合規的最佳實踐
López, Orlando
- 出版商: Productivity Press
- 出版日期: 2020-12-22
- 售價: $3,600
- 貴賓價: 9.5 折 $3,420
- 語言: 英文
- 頁數: 320
- 裝訂: Hardcover - also called cloth, retail trade, or trade
- ISBN: 036761605X
- ISBN-13: 9780367616052
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商品描述
Data 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.
商品描述(中文翻譯)
資料完整性是設計、實施和使用任何存儲、處理或檢索數據的系統中的一個關鍵方面。任何資料完整性技術的整體目的是相同的：確保數據被準確地記錄，並在後續檢索時，確保數據與最初記錄時相同。對數據的任何更改都會追溯到進行修改的人。在病人的電子健康記錄中，數據的完整性對於確保病人的安全至關重要。
本書與製藥和醫療器械產品的生產系統及質量控制系統相關，並更新了實用信息，以便更好地理解適用於電子記錄的控制措施。本書強調電子記錄的適用性實施及相關的風險評估控制，以及電子記錄的處理。本書還提供了來自全球監管機構的最新法規標準，例如英國的MHRA（藥品和健康產品監管局）、美國的FDA（食品和藥物管理局）、中國的國家醫療產品管理局、澳大利亞的TGA（治療商品管理局）、俄羅斯的SIMGP（國家藥品和良好實踐研究所）以及世界衛生組織等。
作者簡介
Orlando 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.
作者簡介(中文翻譯)
奧蘭多·洛佩茲（Orlando Lopez）對於全球監管機構在CSV（電腦化系統驗證）、電子記錄完整性及與生產製造系統、IT系統、分析和商業智慧相關的要求/指導方針方面具有深厚的理解和經驗。
他在治理和系統生命週期（SLC）交付成果的開發方面擁有知識和經驗。他撰寫並部署了CSV方法論至強生（J&J）全球的電腦基礎設施。多次他對受監管公司的電腦驗證方法論進行了重新設計。
奧蘭多·洛佩茲在FDA（美國食品藥品監督管理局）機構的補救行動計劃、監管檢查、回應活動及與同意令相關的驗證方面有直接參與的經驗。
他在《藥物科學與技術百科全書》第四版中發表了第56章《電腦系統驗證》，並撰寫了25篇以上的出版物，包括9本與電腦合規性相關的書籍 - amazon.com/author/orlandolopez/。熟悉差距評估、補救計劃及補救執行活動。
