Development of Advantage~(TM) eFTN: A Good Laboratory Practice Field Data Capture System

摘要

Development of Advantage~(TM) electronic Field Trial Notebook (eFTN) as an easy-to-use and cost-effective GLP field data capture system was driven by the need for manipulation of residue data electronically, favorable user economics, ease of use, GLP compliance, and ease of validation. Both companies and regulators need GLP field data in a database that can be queried. Favorable user economics was addressed by Advantage~(TM) eFTN being free to field researchers. Establishing Advantage~(TM) eFTN as a form-driven system and providing flexibility to move Advantage~(TM) eFTN from one computer to another established ease of use. GLP compliance was addressed by requiring unique passwords and time and date stamps for entering the notebook and saving information, the automatic requirement for data revision records for any data changes, and providing multiple security levels. Self-documenting software validation testing insured ease of validation by the field researcher and facilitated compliance acceptance.