NAICC Abstract:

QA Overview: Electronic Notebook And The GLP Objective

Not too many moons ago, note pad, pencil, maybe "black pen" appeared to be accepted tools for study data documentation. Your adaptability is evident; times do change.

We are aware that many field cooperators are using electronic sources and equipment to record, document procedure, track, calculate, instruct, and summarize field study data. Electronics may facilitate a more timely submission of the final report, but as QA I feel the greatest advantage are data that more accurately translate the aggregated actual test related factors.

GLP regulations are in place to serve as minimal operational guidelines. We will explore reviewed benefits realized by field directed GLP systems and how electronic notebook data documentation may promote GLP expectations.