Hybrid System Qualification

We are using pre-printed quatintine and approved lables as a hard copy. i.e paper record. We are generating electronic data from the system as report by passing required parametes and printing the same on pre-printed lables with signatures.

shall we treat this case as hybrid system. If OK how we complete the quailification for this activity.


Yes this is a classic hybrid system.

The most important aspect of validation here is stating up front perhaps in your Intended Use Document how exactly the system is going to be used.

All of the electronic data will have to be fully validated as this data is used for reporting purposes and maybe used in the future to form some part of a quality decision.

Where are these pre-printed labels originating from, has your printing machine being validated, how do you know that these labels are correct?