Our insight from the industry

At Hyperbolic, we exclusively work with product managers and not project managers. We believe that in a world where software drives everything, the product is indeed the project itself, and not just a part of it.

At Hyperbolic, we see Water Scrum Fall as the perfect balance. We combine the structure of waterfalls with the flexibility of agile, because we know that our customers need both to deliver software that works and complies with regulations.

IT audits from authorities often create nervousness, even in systems that function well on a daily basis. Challenges typically arise due to a lack of overview, insufficient documentation, and uncertainty among employees. Preparation and clear role distribution are crucial.

Configuration errors in GxP systems are often detected too late and can lead to serious deviations. Insufficient access control, lack of documentation, and poor testing of changes are among the most common causes. The solution requires clear roles, control, and culture.

External consultants can enhance IT projects in pharma, but often create compliance risks if roles and responsibilities are not clearly defined. Unclear procedures, lack of training, and weak documentation increase the risk of errors, audit findings, and data integrity issues.

Older IT systems in pharma rarely meet today's requirements for data integrity and validation. Without audit trails or documentation, the risk of compliance breaches increases. This risk can be minimized with compensating controls and a risk-based approach.

In pharma, software updates are complex because they require documentation, validation, and approval according to GxP requirements. Many companies delay updates for fear of operational downtime or compliance issues, but this can increase both safety and regulatory risks.

Digital customer experiences in pharma and regulated industries require a balance between usability and compliance. The article covers portals, dashboards, and documentation - and how IT solutions can be designed with both UX and GxP in mind.

Integration between MES and ERP often goes wrong because the systems are built for different purposes and do not speak the same language. Without precise data mapping and real-time validation, errors occur, which can lead to delays, lost information, and inaccurate inventory data.

When pharmaceutical companies grow globally, managing GxP systems becomes a balance between uniform standards and local flexibility. Without clear governance, one risks both compliance breaches and wasted resources. Effective frameworks and close collaboration are key.

Machine learning holds great potential in pharma, but GxP requirements make it challenging to validate models correctly. The models change over time, which requires documentation, data quality, and continuous monitoring to ensure stable and compliant operations.

With system changes in pharma, data integrity is a central challenge. Errors during migration can lead to lost documentation, distorted batch data, and compliance issues. Therefore, the transfer requires detailed planning, validation, and thorough documentation.