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A Guide to Archiving Electronic Records

A Guide to Archiving of Electronic Records 18th February 2014 A Guide to Archiving of Electronic Records The Scientific Archivists Group (SAG) formed a Working Party to develop guidance to assist in the interpretation and application of the regulations, and to recommend best practice for Archiving Electronic Records . This Guidance Document was produced by that Working Party drawing upon the collective experience of the contributors. The following members of the Scientific Archivists Group participated in the Working Party that produced this guidance. Without their expertise and commitment, this guidance could not have been produced. Authors: Tim Stiles (Chair) Qualogy Ltd Julia Lawrence Unilever, SEAC Neil Gow UCB Eldin Rammell Rammell Consulting Ltd Gary Johnston Audata Ltd Russell Joyce Heath Barrowcliff Consulting Ltd Scientific Archivists Group Page 4 of 26 Copyright 2014by Scientific Archivists Group Limited All rights reserved.

the capture, processing and archiving of electronic records. The principles defined by FDA for Electronic records and Electronic signatures (21CFR11) will similarly need to be applied in the process of archiving electronic records. As with paper records, alterations, modifications or corrections must be appropriately

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