Client: Herlev Hospital
About Herlev Hospital
Herlev Hospital, located in Herlev, Denmark, is a prominent teaching hospital affiliated with the University of Copenhagen. Established in 1976, the hospital is renowned for its modern, functional architecture.
The hospital provides a wide range of medical services, including emergency care, and has a capacity of 1,616 beds. It employs approximately 4,000 staff members who cater to around 82,000 patients annually. The Hospital is dedicated to delivering high-quality healthcare and is involved in various innovative medical projects, such as the validation of new technologies like the APOTECAchemo robot used for chemotherapy treatments
Herlev Hospital's commitment to excellence in medical education and patient care has made it a key player in Denmark's healthcare system.
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).
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.
We needed an advisory and consultancy firm that had extensive experience and knowledge in validating computer systems, and especially could translate this into both usable and, of course, patient-safe solutions.Remember that the chemo robot is a completely new technology that Rigshospitalet and Herlev Hospital are some of the first in the world to implement. Here, their project manager and hands-on validation expert have been a good and safe choice for us.
Mathilde Moe Møldrup, Project leader, Herlev Hospital
Challenge
The validation strategy for the new robot at Herlev Hospital covers its installation, operation, and performance for chemotherapy drug preparation. It also includes in-project training for personnel
Outcome
Installation, operation, and performance validation were conducted according to approved protocols, and all activities were completed and authorized by the competent authority. The APOTECAchemo robot, which supports 55,000 chemotherapy treatments annually, ensures data integrity and patient safety, and is also in use in Aarhus.
