Electronic data archiving document released by ISPE
ISPE, a global not-for-profit association of 25,000 pharmaceutical manufacturing professionals recently released its latest industry-impacting 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.
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 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, the guide has the following features:
Provides an introduction to the complex subject of electronic data archiving, recognizing 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 organizational, 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
This 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.
The 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 provides additional relevant information. ISPE publications are known to provide the practical, ‘real world’ information to help companies build on current best practices to meet and exceed regulatory standards.