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Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance (English Edition) - de Orlando Lopez (Author)
Details Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance (English Edition)
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| Le Titre Du Fichier | Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance (English Edition) |
| Publié Le | |
| Traducteur | Kismat Eilah |
| Nombre de Pages | 870 Pages |
| La taille du fichier | 47.24 MB |
| Langue du Livre | Français et Anglais |
| Éditeur | Marval |
| ISBN-10 | 8256360490-PWN |
| Type de e-Book | EPub AMZ PDF LIT XML |
| Auteur | Orlando Lopez |
| Digital ISBN | 267-5985448721-TIK |
| Nom de Fichier | Data-Integrity-in-Pharmaceutical-and-Medical-Devices-Regulation-Operations-Best-Practices-Guide-to-Electronic-Records-Compliance-(English-Edition).pdf |
Télécharger Data Integrity in Pharmaceutical and Medical Devices Regulation Operations: Best Practices Guide to Electronic Records Compliance (English Edition) Livre PDF Gratuit
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
Presentation on US FDA Data Integrity Guidance 1 This presentation is compiled by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional
After more than 5 years and two draft versions the final version of the Guidance for Industry GfI Electronic Source Data in Clinical Investigations was published in September 2013
Optimize product change management processes at your medical device company for a clear understanding of the data people and processes impacted by change This enables you to effectively plan leverage flexible change processes to meet specific needs and provide full device change traceability
The regulations identified most frequently in CY2018 drug GMP warning letters citing data integrity failures As in past years all data integrity deficiencies identified in Form 483s and warning letters are failures to follow cGMPs as specified in the predicate rules
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Our Intelligent Design Control solution helps medical device companies become datadriven modelbased and document smart by increasing engineering efficiency and speed across the device lifecycle while avoiding costly errors quality issues and recalls