36. audit A systematic and independent examination of study- or trial-related activities and documents to determine whether the activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, standard operating procedures (SOPs), good laboratory practices (GLP) or good clinical practices (GCP), and other applicable regulatory requirement(s).
37. audit trail An essential documented record, often automatically acquired, for an instrument, computer system or process that facilitates reconstruction of events in a chronological manner. Typically includes the date and time of an action, the user name and the action taken.
38. automation The use of automated device(s) to replace manual steps and perform part or all of a bioanalytical procedure.
