Guide tackles electronic archiving

ISPE has released its latest technical publication, "GAMP Good Practice Guide: Electronic Data Archiving".

"Methods by which electronic data archiving is conducted should be practical and efficient, in addition to meeting regulatory compliance expectations," said Per Olsson, Guide Team Leader.

According to its authors, it is generally accepted that there are no commercial off-the shelf" solutions that can comprehensively meet all the demands of the regulated life science sector, and meet security and confidentiality criteria over a number of software and technology platform upgrades and changes.

As such, the guide seeks to provide a rational and scaleable approach to electronic data archiving through the development of an archiving strategy. The implementation of this strategy should help organisations achieve and maintain regulatory compliance, and to effectively manage electronic records over the long term.

The guide addresses management, planning, development, operational, and compliance issues, and current GxP regulations related to archiving have been taken into account.

It covers a number of concepts, issues, and practices as they apply to the complex and developing subject of electronic data archiving, including the fundamental role of the Archiving Strategy document.