A Guide to Archiving of Electronic Records - Tapa blanda

Stiles, Tim

 
9780955765926: A Guide to Archiving of Electronic Records
Tapa blanda
ISBN 10: 0955765927 ISBN 13: 9780955765926
Editorial: Scientific Archivists Group Limited, 2014

Sinopsis

The retention and archiving of study materials and process records, raw data and source data, is a critical part of compliance with both Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The maintenance and retention of such records provides the means by which a study, trial, process or procedure can be reconstructed and thus enabling the information and results generated to be verified. Requirements for the operation of an archive and the archiving process for electronic records are no different to the requirement of physical records which are required to be retained for regulatory or business requirements. However, due to the variety and fragility of electronic records some additional features are required. The purpose of this document is to identify and discuss these features and provide guidance on how these challenges can be met.

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Reseña del editor

The retention and archiving of study materials and process records, raw data and source data, is a critical part of compliance with both Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The maintenance and retention of such records provides the means by which a study, trial, process or procedure can be reconstructed and thus enabling the information and results generated to be verified. Requirements for the operation of an archive and the archiving process for electronic records are no different to the requirement of physical records which are required to be retained for regulatory or business requirements. However, due to the variety and fragility of electronic records some additional features are required. The purpose of this document is to identify and discuss these features and provide guidance on how these challenges can be met.

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Editorial
Scientific Archivists Group Limited
Año de publicación
2014
Idioma
Inglés
ISBN 10 
0955765927
ISBN 13 
9780955765926
Encuadernación
Tapa blanda
Número de páginas
40
Contacto del fabricante
no disponible
Persona responsable
no disponible