R2-R3 conversion of data is a delicate activity that requires the following steps:
- Upgrading of data to R3 format through EMA BFC tool or, in case of Excel sheet, normalization of data and adherence to R3 accepted values;
- Drafting of a conversion map to define the exact location of E2B and non-E2B data in SafetyDrugs6;
- Development of migration scripts;
- Execution of dry run tests to verify the success of the migration process;
- Execution of quantitative validation;
- Upon customer’s request, execution of the qualitative validation;
- Copy of the test environment, with the data contained therein, in the production environment. Provision of the related protocol.
You can learn more by reading the article Here’s how we safely convert your data into R3.