Additional Controls for processing the raw data on different computers (processing system)

[v9991]

its conventional and general practice to process the data on the same instrument where the data is generated;

generally for client-server or network systems the data is hosted on central computer and the client systems access the same data from server; thus avoiding the technical problems; however, in this case, instrument system has capability of acquiring data + processing; and processing system is intended for processing alone; and both will be operational in the lab.

what are the additional controls required to be put in place for processing the data on a different system; (i.e., data generated on instrument-computer - and data processed and reported from different computer)


thank you for your thoughts and guidance.

 

[yodon]

I would think this should be covered in your validation work. A conservative approach would be to validate on each system in use. You might be able to make a case for similarity of systems (thus not having an effect on the processing) but it may be a hard sell. A practical approach might be to fully validate on one system and do partial validations on the other systems.

 

[v9991]

I would think this should be covered in your validation work. A conservative approach would be to validate on each system in use. You might be able to make a case for similarity of systems (thus not having an effect on the processing) but it may be a hard sell. A practical approach might be to fully validate on one system and do partial validations on the other systems.

we do have same approach ;
so, having the 1st system with instrument to analyse (acquire data); and using 2nd (duly validated) system to process the data is acceptable.

 

[yodon]

Should be, as long as you provide the rationale for why you believe it's acceptable.

 

[v9991]

Should be, as long as you provide the rationale for why you believe it's acceptable.

So., apart from validation... Are tgere any otger criteria to be cinsidered.


We have controls and reconciliation yo ensure that there is no redundancy/duplication in processing data

 

[yodon]

Without being more intimately familiar with your system, I can't think of anything. As with pretty much everything, it's all about risk. If you've done due diligence to ensure the operations are not compromised, you should be in good shape.