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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.
#Pharma #Design #Validation #Annex11 #Part11 #Training

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Henrik Johanning

CEO & Seniorkonsulent
IT & Automation / GAMP, Regulatory Affairs, Project Management, Management Consulting, GMP, Træning