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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