Background

The state of automation and data processing for transfusion medical facilities in connection with patient care clinics will be presented at the 56th Annual Congress of the DGTI in Berlin.

New practical solutions are used to show examples of GAMP5 validations and GMP Guide Annex 15 for routine qualification for hospitals, transfusion facilities and medical facilities on the new Internet website in the DGTI members' area.addition.

Methods

The state of automation and data processing techniques will be discussed for selected topics.

With the involvement of external speakers, institutions, authorities, solution examples for the implementation of GAMP5 and GMP Guide in the routine for hospitals, transfusion facilities, and medical facilities are to be recorded, taking into account legally binding guidelines.

In order to implement the specifications for the validation of methods, the qualification of devices according to GMP Guide Annex 15, and for risk-assessing decisions according to GAMP, the following topics should be presented in the automation and data processing session.

Results

These sample qualifications and validations are to be published from last year on the previous DGTI platform. The results are to be made available on the new DGTI website with results for sample qualifications and validations. Both the main topics presented in the meeting of the Automation and Data Processing section at the digital DGTI Congress in Vienna in 2021 and the topics presented in Berlin 2023 should be made available on the digital platform in the members' area. The following topics were presented at the digital DGTI Congress in Mannheim in 2022.

Status of digital patient file, electronic entry of organ donation in the register

Critical IT infrastructure for blood donation services (KRITIS)

- Environment of digitization IT sector

Conclusion

For the automation and data processing meeting at the 56th annual meeting of the DGTI in Berlin, stipulations on the setting of qualification and validation solutions on the DGTI website are to be adopted for rapid implementation. For this purpose, the new DGTI website should be approved by the board for the section work.

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