It may be prudent to state that a Pharmacovigilance professional may have had experienced or participated in at least one Safety data migration project in his/ her lifetime, either directly or indirectly. Scaling up of Pharmacovigilance Systems is generally associated with up-gradation of Safety database, infrastructure updates (? change from on-premise to Cloud) or even Change in database. All of these situations may be associated with Safety Data migration.

Safety data migration is inevitable in the following situations:

1. Merger and Acquisitions

2. Setting up a Pharmacovigilance System

3. Change in Database

4. Database upgrade

Although there are numerous vendors or service providers having expertise in this area, pharma companies (especially the large or aggressively growing ones) may even consider having in-house expertise in this area, or a combination of in-house and external support.

At the end of the day, one should remember that this is one of the favourite areas for auditors and inspectors.

Why are inspectors interested in evaluating the safety data migration projects?

1. Adequate Documentation

2. CSV Approach

3. Availability of ICSR Source Documents

4. Completeness of migrated safety data

5. Project management plan and agreement/ contract

6. Audit Trail Availability

Types of Safety Data Migration

1. Manual Entry and processing

2. Migration from Excel

3. E2B-XMLs

4. Data Dump

5. Combination Methods

Challenges in Safety Data Migration

1. Incomplete migration

2. Non-Availability of source documents

3. Incomplete documentation

4. Approach related issues

5. Issues with Audit Trail

6. Incomplete data in PSURs

7. Missed Expedited Reports and Duplicate Reports

A safety data migration project increases the chance of having an inspection, by multi-fold.

Thanks to the well-formulated intelligence system and media, that helps the inspectorate offices in keeping track of mergers or acquisitions. Not to forget, this may even be one of the reasons for a triggered inspection.