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2018-11-09
Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories - de R D McDowall (Author)
Details Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories
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| Le Titre Du Livre | Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories |
| Sortié Le | 2018-11-09 |
| Traducteur | Letrell Nina |
| Quantité de Pages | 538 Pages |
| Taille du fichier | 30.32 MB |
| Langue | Français et Anglais |
| Éditeur | Delcourt |
| ISBN-10 | 7605303374-GNT |
| Type de Données | AMZ PDF EPub CCF QUOX |
| de (Auteur) | R D McDowall |
| ISBN-13 | 483-2674889499-UTR |
| Nom de Fichier | Data-Integrity-and-Data-Governance-Practical-Implementation-in-Regulated-Laboratories.pdf |
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La maitrise de la Data Integrity est devenue une préoccupation majeure des autorités de santé et pas moins de 6 guidelines 1 ont été publiés depuis 2016 sur le sujet par différentes instances réglementaires
The Data Integrity Working Group DIWG includes participants from over 15 PICS Participating Authorities and the remit of the group is to develop harmonised guidance for inspectorates with regard to the expectations for Data Management and Integrity for GMP and GDP regulated entities
Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA
Securely managing regulated data is a governance issue for many organisations As nextgeneration threats and stealth attacks continue to rise cybercriminals are leading highprofile attacks against organisations
“DATA INTEGRITY” “Data integrity refers to the accuracy and consistency of data generated during GxP” “Data integrity is a prerequisite for the regulated healthcare industry as decisions andy assumptions on Product quality and Compliance ith th li bl l t i twith the applicable regulatory requirements are made based on data” Girish A Swami PGDIPR PGDDRA
data integrity confidentiality and privacy arising from regulatory and market pressure around protecting personal data protection legislation and corporate data fair disclosure regulations as well as financial and operational data Sarbanes Oxley