Safety Data Migration can be undertaken using the following methods:

1. Manual Entry and processing: Simplest, cost-effective, and suitable for small datasets (~100 ICSRs). The ICSRs are manually entered into the new system; source documents are attached.

2. Migration from Excel: The ICSR data is extracted from the spreadsheet database and migrated into the safety database.

3. E2B-XMLs: The ICSRs are extracted as individual XML files or batches of reports, either in the E2B-R2 or R3 format and imported into the safety database.

4. Data Dump (Programmatic migrations): This is the most complex but effective form of migration involving resources and costs. These are suitable for massive datasets, and such processes are common following M&A.

5. Combination (Hybrid) Methods: This is more cost-effective than the programmatic migrations. One example is the combination of E2B-XML migration followed by the migration from the spreadsheet containing the non-E2B fields.

There is no right or wrong way to migrate Safety Data. Every method may have its own set of advantages and limitations. Audit Trail migration may remain a challenge in any data migration. Besides, it is not necessary to follow a single methodology. Combination methods are also a viable option.

One should be able to defend in front of the inspector that necessary fields and information were not missed and documentation was adequate, with appropriate quality governance processes.