DCS Validation

My client is installing a DCS is a pharmaceutical plant and is seeking to the following approach to the CSV:

  1. Take customer URS and develop all lower-level specs (design/functional) as per GAMP.
  2. Conduct FAT – this will verify all software functionality.
  3. Conduct SAT – this will verify installation of the software/hardware on customer site and integration with the customer’s IT infrastructure where applicable. This would then be the end of CSV from the DCS supplier’s perspective.
  4. My client then proposed that the customer’s IQOQ of the complete system (i.e. the DCS itself and the process equipment) will be used to verify end-to-end functionality of the complete system.

Does this seem like a reasonable approach and are there any other things to consider ?

All advice gratefully accepted

The subject of this case study is a Distributed Control System (DCS) validation project that was part of the automation of a new biotech pilot plant. In this project, schedule-crashing delivered a complex, compliant DCS to the plant below cost without compromising quality.