Are you about to switch IT systems? Here's how to ensure that your data remains valid and compliant.

Why data integrity is challenged during system changes

When pharmaceutical companies switch IT systems, one of the biggest concerns is often how the data is handled during migration. The reason is simple: Data integrity is extremely important in the industry, and errors or loss of data can lead to serious compliance challenges. The requirements from the FDA and EMA regarding data integrity mean that migration between GxP systems must be handled with particular care.

In practice, this means that data must be moved accurately, without losing or distorting important information. If something goes wrong during migration, it can have consequences for both the quality of the products and the company's regulatory status. And unfortunately, we often see that companies underestimate the scope of the task and the importance of detailed planning.

What problems can arise from poor migration?

If data integrity is not sufficiently ensured during a migration, it can lead to serious consequences. Incorrect or incomplete transfer of data means losing documentation for processes, quality assurance, or batch histories. In the worst case, problems are only discovered during an audit, which can lead to significant compliance challenges and potentially severe sanctions.

Another issue is that data that is distorted during migration can cause problems far into the future. Uncertainty about the validity of the data can lead to errors in production, inadequate or incorrect reports, and ultimately compromise both patient safety and the company's credibility.

How to ensure effective migration and data integrity

To avoid these challenges, it is crucial to have a detailed and documented migration plan. The plan should precisely describe which data is being migrated, how it is validated, and what control measures ensure integrity along the way. A good migration plan should also include clear guidelines for risk management, so that it is known in advance how to handle any errors quickly.

Practically, it is important to start with a comprehensive mapping of existing data and their relationships. This involves a thorough review of the existing data formats, validation requirements, and regulatory documentation requirements. Once this mapping is in place, the actual migration process becomes more manageable and controllable.

Another key element is testing and validation of migrated data. This should be done in controlled environments, ensuring that the data retains its integrity and accuracy after transfer. It is important to involve both technical experts and QA personnel early in the process to ensure that testing and validation are conducted in the most optimal way.

Finally, the entire migration process should be documented carefully. The documentation should clearly show which data was migrated, how it was validated, and what the results were. If something goes wrong, this way you always have clear trails to follow.

If you want to learn more about how to best ensure data integrity during system changes in pharma, feel free to reach out to us for an informal discussion.