Max Application has developed a structured process for the migration and validation of pharmacovigilance data between pharmaceutical companies. The solution includes the creation of technical analysis documents, information mapping, risk assessment, and project planning, along with testing and validation activities. All steps are coordinated through regular meetings to monitor progress and ensure that the data are accurately transferred and correctly integrated into the receiving companies’ databases.
case-studies
Pharmacovigilance data migration
Approach and methodology
ChatGPT haThe project involved the complete management of pharmacovigilance data migration between pharmaceutical companies, following a structured and highly controlled approach. Several key documents were prepared: technical analysis, information mapping, Risk Assessment, Migration Project Plan, RACI matrix, test plan, and validation plan. These documents were shared with all stakeholders to ensure transparency, coordination, and traceability throughout the entire process. The project involved the complete management of pharmacovigilance data migration between pharmaceutical companies, following a structured and highly controlled approach. Several key documents were prepared: technical analysis, information mapping, Risk Assessment, Migration Project Plan, RACI matrix, test plan, and validation plan. These documents were shared with all stakeholders to ensure transparency, coordination, and traceability throughout the entire process.During the project execution, regular meetings were held to monitor progress, discuss potential issues, and update activities according to operational needs. This approach ensured that the data migration was carried out accurately, securely, and in compliance with regulations, minimizing risks and guaranteeing the full integrity of the transferred information.
A technical analysis document, an information mapping document, the Risk Assessment, the Migration Project Plan, the RACI matrix, the test plan, and the validation plan are carefully drafted. These documents are presented to all stakeholders involved. Regular meetings are held to continuously track the project’s progress.
Staff involved in the project
3
Specialists
Execution time
6
Months
Technologies used
- Oracle Forms
100
%
Achievement of a regulatory requirement
100
%
Data normalization
Get in touch with
Abacus Group
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