The scope of 21 CFR Part 11 includes operational areas of pharma, biotechnology, or medical devices companies such as — manufacturing, maintenance, and laboratory.
EDC 21 connects 8 nos. Labindia make instruments via 8nos. RE-01 Ethernet modules based on advance Ethernet technology. Data from all 8 instruments is captured on a single PC simultaneously i.e. Centralized collection of data. It is Single license software, Multi Instrument – Multi User concept.