How to store source data to meet GLP requirements

The long-term archiving of digital raw (or source) data is critical to:

• Ensure compliance with Good Laboratory Practice (GLP)
• Meet the requirements of data integrity guidance issued by regulatory authorities
• Achieve inspection readiness

This is important because GLP data provides the means by which a study, project, activity or process can be reconstructed - and the results generated can be verified.

The archiving of raw data can be challenging and requires careful planning if the integrity of that data is to be preserved and for it to remain accessible, readable, and (where necessary) usable throughout the entire duration of its required retention period. From a regulatory perspective, there is little difference in the principles associated with the archiving of paper and electronic data, except that electronic data requires additional considerations and challenges.