ISPE has just 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", according to Per Olsson, guide team leader.
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 confidentially criteria over a number of software and technology platform upgrades and changes.
Although such commercial solutions are in development, it is unlikely that future archiving needs can be fully addressed using 'off-the-shelf' offerings.
The ISPE GAMP Good Practice Guide: Electronic Data Archiving 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.
Current GxP regulations related to archiving have been taken into account in developing this guide.
Specifically, this Guide:.
- Provides an introduction to the complex subject of electronic data archiving, recognising the differences from the traditional paper archive.
- Provides a process for creating and implementing an archiving strategy.
- Highlights considerations in determining an archiving strategy, at an organisational, technical, and regulatory level.
- Identifies those aspects of technology that have an impact on the selection of an archive solution, which are independent of specific technical solutions.
The guide 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.
The intended audience for this guide consists of those individuals who:.
- Need to archive electronic records (particularly regulated records).
- Have accountability for stored electronic records.
This includes the Archivist or Archive Administrator, and those with management responsibility for providing records to both regulators and business users.
- Need to access archived electronic records.
- Are tasked with implementing an electronic archive (this includes IS/IT specialists and Suppliers).
- Are responsible for the funding of the electronic archive.
The audience for this guide will, therefore, include individuals from many disciplines as well as IS/IT specialists.
This guide is intended as a supplement to the main GAMP Guide and is read in conjunction with the ISPE GAMP Good Practice Guide for Electronic Records and Signatures, which provide additional relevant information.
The 152 page guide is priced for Members at USD145 or 110.00 Euros; and nonmembers at USD215 or 165.00 Euros.
