Customising a Digital Solution to Ensure Data Integrity in Hospital Pharmacy Formulation and Dispensing Processes

Good pharmacy and manufacturing practices identify data integrity as a critical factor for patient safety. However, many of the processes in hospital pharmacies are still documented manually, which can compromise the integrity of the information. This work presents a software customization prototype for data integrity assurance in hospital pharmacy formulation and dispensing processes. The proposed solution combines the implementation of ALCOA+ principles by design, GAMP5 V-model and human-center design methodologies to adapt a validated data integrity software for a hospital pharmacy use case. Moreover, our proposal is being evaluated in the hospital pharmacy environment to achieve a higher readiness level. After complete validation, the software customization can support the digitalization of drug formulation and dispensing processes and improve patient safety.