How to handle regular software updates under GxP

Why software updates are difficult in pharma

One of the things we often experience with our pharma clients is a significant concern regarding regular software updates. The reason is the extensive GxP requirements that regulate quality, safety, and efficacy within the industry. Although software must be updated regularly to remain secure and functional, it is not quite so simple in pharma. The updates must be documented, validated, and approved according to stringent regulatory standards.

In practice, this means that many companies end up postponing or completely avoiding necessary updates because the process seems overwhelming. Often, this is due to the fear that the updates will negatively impact compliance or create problems in daily operations. And although this fear may be justified, it is, in the long run, both a safety and regulatory risk to postpone updates.

Consequences of delaying updates

When software is not kept up to date, it can lead to serious security risks. Older versions of software are often more vulnerable to hacking attacks or data breaches, which can have significant consequences for both patient safety and the company’s reputation. Additionally, a lack of updates can make it more difficult to meet regulatory requirements because authorities like the FDA and EMA expect systems to be updated and compliant.

Another problem arises if a necessary update is postponed for too long. This can result in the process becoming even more complex and costly when the update finally needs to be implemented, as the changes are now more extensive and harder to manage.

How to ensure smooth updates under GxP

Fortunately, there are good methods for handling software updates in a more efficient manner. It is especially about having a structured process for validation and documentation.

First and foremost, one should have a clearly defined validation strategy that clearly states how and when software updates are validated. This strategy should include guidelines for risk assessments, test protocols, and documentation requirements. By having these guidelines clearly defined and approved in advance, the validation work itself becomes more manageable.

Moreover, it is crucial to conduct regular risk assessments of the updates. Not all software updates are equally extensive or risky. A minor security update may not require the same in-depth validation as a major functional change. By continuously assessing the scope and risk of updates, one can significantly streamline the validation process.

Finally, it is important to have a clear procedure for the actual implementation of updates. The procedure should describe how updates are tested in controlled environments, how communication occurs with users, and how any errors are handled quickly.

If you want to know more about how to best handle regular software updates under GxP requirements in the pharma industry, feel free to reach out to us for an informal discussion.