Case

Facility Monitoring System

Hospital Pharmacy, Central Denmark Region

Challenge

Requirement specification and risk assessment of a facility monitoring system (FMS) at the new hospital pharmacy in Gødstrup.
FMS is monitoring GxP-critical parameters that may have impact on product quality in biosafety cabinets, isolators, clean rooms, production rooms etc.
Support in the process of purchasing and vendor management
Time schedules covering both Gødstrup and Skejby (from design qualification to operation in Gødstrup in March 2022, and Skejby in Q1 2024).
Authoring of documentation including change control, validation master plans, validation plans and protocols/report including deviations.
Validation activities covering installation and operation qualification.

Vores nye FMS er vigtigt for patienternes sikkerhed. Derfor var det vigtigt for os at få kompetent rådgivning og hand-on support, så vi fra begyndelsen fik lagt den rette valideringsstrategi og sikret, at FMS var klar til idriftsættelsen af apotekets lokaler i Gødstrup.

Genau & More har været det rigtige valg med et højt fagligt niveau og gode samarbejdsrelationer. Det betød, at vi på trods af corona-nedluk og geografiske afstande mellem Skejby, Gødstrup og hjemmearbejdspladser altid har kunnet været trygge ved kvaliteten af arbejdet fra Genau & More.

Charlotte Quist Bjørn

Quality Manager, Hospital Pharmacy Central Denmark Region

Solution - Proces

The primary form of work was remote as the hospital pharmacy was under construction.
Bi-weekly status meetings with the project group including update on actions, documents, challenges etc.
Close collaboration with users and the team in Gødstrup in order to secure the design qualification.
Onsite/hands-on according to the implementation, configuration and qualification of the FMS, where working in the clean room and walking on celling.
Validation Master Plan describing the chosen Validation Strategy based on the Golden-Light Strategy, where one IT-system needs to be implemented on two different sites in two different timespans.

Results

Identified deviations during installation and operation qualification were approved and closed.
All relevant documentation shared with the facility monitoring system (FMS) in Skejby was updated following the implementation/qualification. This included the risk assessment, design qualification report, and requirement specifications.
FMS was put into operation in March 2022 at Regionshospitalet Gødstrup with a total of 6 particle counters and 74 sensors measuring temperature, pressure and humidity.
Following an inspection from the Danish Medicines Agency, where the FMS project was of core interest for the inspectors during the 3-days inspection (2 inspectors), the implementation and operation of FMS was approved.