There are five stages in the transition to the new software:
- Initial analysis of the project: the integration path is presented to the customer and all the necessary information to prepare the new process is provided.
- Development of the data migration plan: the structure of the original database, software or Excel sheet, is analyzed and the migration mapping is drafted. Upon the data migration conclusion, the quantitative/qualitative data migration validation is performed.
- System validation: the validation of a computer system, CSV – Computer system validation, is the whole process that documents the compliance of the safety database with the requirements defined by the EMA and FDA guidelines and by the configuration specification required by the client.
The Performance Test phase, see us alongside the customer to support him with our expertise in carrying out the tests.
- Training: it usually takes four days to train both operator and administrator users. At the end the corresponding certifications are provided.
- Go live: you can start performing your pharmacovigilance activities in SafetyDrugs, the ICH E2B (R3) native safety database.
You can learn more by reading the article ICH R3: how long does it take to integrate SafetyDrugs into business processes?