Data Integrity in Pharmaceutical and Medical Devices Regulation Operations - Couverture souple

Lopez, Orlando

Couverture souple

ISBN 10 : 1032339888 ISBN 13 : 9781032339887

Editeur : Productivity Press, 2022

Synopsis

Data 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.

A propos du livre

À propos de l'auteur

Orlando Lopez

E-records Integrity SME

Durham North Carolina USA

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 (Taylor & Francis Group, LLC) and had written 25+ publications, including 9 computer compliance related books - amazon.com/author/orlandolopez/

Familiar with gap assessment, remediation planning and remediation execution activities.

À propos de la quatrième de couverture

Data 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.

Détails de l'édition

• Éditeur: Productivity Press
• Date d'édition: 2022
• Langue: anglais
• ISBN 10: 1032339888
• ISBN 13: 9781032339887
• Reliure: Broché
• Nombre de pages: 372
• Coordonnées du fabricant: non disponible
• Personne responsable: gpsr@libri.de; gpsr@libri.de; ; Europaallee 1; Bad Hersfeld; 36244; Allemagne