{"product_id":"data-integrity-in-pharmaceutical-and-medical-devices-regulation-operations-best-practices-guide-to-electronic-records-compliance-paperback","title":"Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance - Paperback","description":"\u003cp\u003eby \u003cb\u003eOrlando Lopez\u003c\/b\u003e (Author)\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eData integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years' experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.\u003c\/p\u003e\u003ch3\u003eAuthor Biography\u003c\/h3\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eOrlando Lopez\u003c\/strong\u003e \u003c\/p\u003e\u003cp\u003eE-records Integrity SME\u003c\/p\u003e\u003cp\u003eDurham North Carolina USA\u003c\/p\u003e\u003cp\u003eOrlando 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. \u003c\/p\u003e\u003cp\u003eHe has knowledge and experience in the development of governance and SLC deliverables. Wrote and deployed CSV methodology to computer infrastructure J\u0026amp;J worldwide. Several times he had re-engineered the computer validation methodology to regulated companies.\u003c\/p\u003e\u003cp\u003eOrlando Lopez has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications.\u003c\/p\u003e\u003cp\u003eHe is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation (Taylor \u0026amp; Francis Group, LLC) and had written 25+ publications, including 9 computer compliance related books - amazon.com\/author\/orlandolopez\/ \u003c\/p\u003e\u003cp\u003eFamiliar with gap assessment, remediation planning and remediation execution activities.\u003c\/p\u003e\u003cdiv\u003e\n\u003cstrong\u003eNumber of Pages:\u003c\/strong\u003e 396\u003c\/div\u003e\u003cdiv\u003e\n\u003cstrong\u003eDimensions:\u003c\/strong\u003e 0.81 x 10 x 7 IN\u003c\/div\u003e\u003cdiv\u003e\n\u003cstrong\u003eIllustrated:\u003c\/strong\u003e Yes\u003c\/div\u003e\u003cdiv\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e July 12, 2022\u003c\/div\u003e","brand":"Books by splitShops","offers":[{"title":"Default Title","offer_id":51782516605216,"sku":"9781032339887","price":77.74,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0974\/9764\/5344\/files\/565dc552b15c344e10bcac0e357335bf.webp?v=1780572904","url":"https:\/\/ebocreations.com\/products\/data-integrity-in-pharmaceutical-and-medical-devices-regulation-operations-best-practices-guide-to-electronic-records-compliance-paperback","provider":"The E-Book Oasis LLC","version":"1.0","type":"link"}