Typical configuration errors in pharma: How to avoid them

Why configuration errors are a real problem

Configuration errors are among the most common causes of deviations and compliance breaches in GxP systems. They often occur in the background and are only discovered when something goes wrong. Configuration management may sound like a technical detail, but in practice, it has a direct impact on data integrity, traceability, and system reliability.

The errors can range from incorrect user rights and missing alarms to unintended changes in system settings that are not caught in time. Regardless of the type, they share the commonality of potentially leading to deviations, inadequate documentation, and in the worst case, regulatory sanctions.

Typical errors and why they happen

One of the most common mistakes is insufficient access control. Users are granted too many rights or are not removed when they change roles. This means that the system loses control over who has done what, which is a clear violation of GxP requirements.

Another classic problem is the lack of versioning and documentation of configuration changes. If one does not clearly document what has changed, when, and why, it becomes difficult to recreate the system's history. This makes it nearly impossible to demonstrate compliance during an audit.

Errors also occur when changes are not tested thoroughly enough. It may be a configuration change that appears innocent but has unintended consequences for data or functionality. Without adequate testing and validation, it is often only discovered when the damage has been done.

How to avoid the errors

The first step is to clarify roles and responsibilities. There should be clear procedures for who may make changes to configurations and how changes are approved and documented. A central configuration register can help create an overview and ensure that all changes are properly recorded.

Next, permanent controls should be established for how and when configurations are reviewed. This can involve regular reviews where access rights, alarm settings, and any changes in system settings are checked.

Testing and validation should also be an integral part of the process. Any change in configuration should be tested in a controlled environment and documented as part of the validation package. This provides both security and traceability.

Finally, it is about culture and awareness. Configuration management should not only be something that resides with IT. It should be thought of as part of the daily compliance work and be a natural part of the collaboration between IT, QA, and the business.

If you want to know more about how to avoid typical configuration errors in pharma, feel free to reach out to us so we can have an informal chat.