IT audits without stress: How to handle the authorities' requirements

Why IT audits can create nervousness

When pharmaceutical companies are visited by authorities such as EMA or FDA for an IT audit, it can quickly become a somewhat stressful situation. Although the systems generally function well in daily operations, it is a different matter when everything suddenly needs to be documented and explained. Many experience that they do not feel fully prepared, which makes the audit process unnecessarily stressful.

It rarely has to do with bad intentions or poor technology. It’s about documentation, overview, and preparation. The authorities do not come just to see if the system works, but whether it is validated, managed, and documented in a way that meets GxP requirements.

What typically goes wrong?

A classic mistake is a lack of overview of which systems are GxP-relevant. If one does not have an updated system catalog with clear documentation of validation status and compliance level, it can lead to doubts and lengthy explanations during the audit.

Another problem arises when companies cannot account for changes in the systems. If there are no clear change logs or if configuration changes are not documented, it creates uncertainty about the system's stability and compliance.

Finally, there is the human factor. If those who are to participate in the audit do not feel secure in the process, it can lead to inaccurate or uncertain answers. This can give the authorities the impression that the company does not have control over its systems even though that is not the case.

How to best prepare

The most important thing is to be proactive. Begin by mapping all GxP-relevant IT systems and ensuring that the documentation for them is updated and easy to find. This includes validation documents, risk assessments, SOPs, and any deviations or change logs.

Also, ensure that the employees who are to participate in the audit know exactly what their role is. Arrange a short preparation meeting where the most important questions that may arise are reviewed. This creates confidence and ensures that the answers are consistent and precise.

During the audit itself, it is important to be open and collaborative, but also clear about what can be shown and what requires further context. If there is something that cannot be answered immediately, it is better to say so honestly and follow up afterward.

After the audit, one should follow up, both internally and possibly with the authorities if there were questions or points that require action. This shows that the company takes the audit process seriously and uses it as an opportunity for improvement.

If you want to know more about how to best handle IT audits from authorities without making it a stress factor, feel free to reach out to us so we can have a non-binding conversation.