My client is installing a DCS is a pharmaceutical plant and is seeking to the following approach to the CSV:
- Take customer URS and develop all lower-level specs (design/functional) as per GAMP.
- Conduct FAT – this will verify all software functionality.
- 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.
- 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