Challenges in archiving electronic bioanalytical data supporting GLP studies in a CRO

The purpose of this article is to articulate the fundamental issues of archiving electronic GLP data in a CRO environment. CROs struggle to address the absolute requirement of archiving GLP studies electronically. The difficulty of adhering to this is partly due to the wide variety of systems and types of electronic data. Often the end solution to this complicated issue is printing the data at the end of the study and in turn archiving the paper data, foregoing or ignoring the fact that scientific decisions were made while reviewing electronic data. Paper data and electronic data can be different. For example, chromatographic resolution or being able to focus in on detailed integration of chromatograms can significantly change the perspective of the data. While the core goal of archiving according to GLP principles are met, the reality is much different. Businesses purchasing CRO capabilities and regulatory agencies have been quite clear that when it comes to auditing the data that the electronic record is the preferred and often required source of the information for auditing and review purposes. The fact is that paper data do not always provide the flexibility, sensitivity and complete data context that an electronic record can provide. The ability to adhere to compliance standards due to the electronic data cannot be undervalued and by printing the data after all the acquisition, decisions, scientific judgments and review, do a complete disservice to the multidimensional (such as colors for deactivated or changed data, audit trails, 'zooming-in functionality', direct data links and snapshots) data in an electronic system.