Composite Batch Report and 21 CFR 11

Overview:

New technologies bring a step change in the availability, flexibility and quality of data for reporting. Batch reporting can be considered to be made up of three elements (1) automated actions by the control system, (2) manual actions and records by an operator and (3) process values. Windows technology has made the combination of (1) and (2) routine but combining (1), (2) and (3) into a single report has been elusive. In addition within the regulated industries the integrity of such a report has to be assured.