A Guide to Archiving of Electronic Records - Couverture souple

Stiles, Tim

 
9780955765926: A Guide to Archiving of Electronic Records
Couverture souple
ISBN 10 : 0955765927 ISBN 13 : 9780955765926
Editeur : Scientific Archivist Group, 2014

Synopsis

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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Présentation de l'éditeur

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.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
Scientific Archivist Group
Date d'édition
2014
Langue
anglais
ISBN 10 
0955765927
ISBN 13 
9780955765926
Reliure
Broché
Nombre de pages
31
Coordonnées du fabricant
non disponible
Personne responsable
non disponible