The customer for this project needed a recording system which was accurate and secure so data could be submitted to the FDA. The system was required to be validated.
This involved breaking into existing current loops for calibrated instruments to enable them to be connected in series to individual channels on the Eurotherm electronic chart recorder.
The system was split into three pre-defined areas requiring a chart recorder for each area. Each area was then broken down into pre-defined groups to allow grouping of chart pens (channels) for comparative data.
The setup of the recorders were captured in various design documents including FDS, HDS and SDS. The validation of the system was proved using IQ, OQ and PQ testing and documentation. |