Case

Validation of chemo robot

Herlev Hospital

Challenge

Validation strategy of new robot in the hospital pharmacy to be used for identification and mixing of drugs used for chemotherapy at Herlev Hospital.
Validation must cover installation, operation and performance of the robot, incl. readiness for scale-up.
In-the-project training of personnel (project, operation & maintenance).

Vi havde brug for et rådgivnings- og konsulenthus, som havde tung erfaring og viden inden for validering af computersystemer, og især kunne omsætte dette til både brugbare og selvfølgelig patientsikre løsninger.

Husk på, at kemo-robotten er helt ny teknologi, som Rigshospitalet og Herlev Hospital er nogle af de første i verden til at implementere. Her har Genau & More og deres projektleder og hands-on validerings-ekspert været et godt og sikkert valg for os.

Mathilde Moe Møldrup

Projektleder, Herlev Hospital

Solution - Proces

Project management.
Validation Master Plan (VMP) describing criticality assessment, validation strategy and planning, validation deliverables, training and instruction, and reporting.
Design validation.
Test plans for installation, operation, and performance validation activities, incl. the surrounding clean room.
All requirements were addressed in a requirement traceability matrix (RTM) in order to secure sufficient scope in validation.

Results

Installation, operation, and performance validation was performed based and approved protocols.
All validation activities were completed and approved, and the robot authorized for operation by competent authority.
Data integrity (EU EudraLex Annex 11 and FDA 21 CFR Part 11) was crucial in securing patient safety and therefore essential part of the validation activities.
The robot is supporting on 55.000 chemo-therapytreatments annually.
The APOTECAchemo robot is also in use in Aarhus.