The HSRAA publication “A Guide to Archiving of Electronic Records (2nd edition)” is now available.
The retention and archiving of study materials and process records, raw data and source data, is a critical part of compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
The maintenance and retention of study records is essential to ensure that a study can be reconstructed and the data generated can be verified. Requirements for archiving of electronic records are no different to those for physical records. However, the variety and complexity of electronic records requires some additional considerations. The purpose of this document is to identify and discuss these features and provide guidance on how best to meet these challenges.
This revised guide has been updated to encompass the many developments that have occurred in the field of electronic archiving since the first edition was published.
HSRAA members can download a copy for free in PDF format, from the Publications for members section of the Document Library.
Non-members will be able to purchase a printed copy from our online publisher for £10. We will update this page and make an announcement when the facility is available.