GxP data governance

Thanks to our customised IT services for data governance, organisations can rest assured knowing that they are already compliant with the forthcoming tighter regulations.

Ready for 2026?

The update to EU GxP Annex 11 will take effect in 2026 with stricter criteria for automated systems that monitor consistency, reliability and compliance with GxP standards. In recent years, data control in the digital world has received little attention, but that is set to change with the impending alterations to EU regulations.

Would you like to know more about how we take GxP data governance to the next level? Contact us for an obligation-free consultation

Digitalising the GxP environment: the time is now

Many pharmaceutical companies often fall short in terms of data integrity and data governance. Common issues include:

  • no automated backups
  • no data-archiving processes
  • user management allows unauthorised adjustments to laboratory equipment

In addition, processes are still routinely documented on paper. With tighter regulation approaching, now is the ideal time to digitalise the GxP environment.

 

Fully documented and validated

All our IT services are tailored to the unique needs and challenges of an organisation. However, our solutions have one thing in common: they ensure that pharmaceutical companies not only gain more control over their processes but also meet stringent requirements for data continuity and data availability.

For example:

  • Secure backups and data recovery
  • File-level blockchain security for data authentication
  • Disaster recovery for hardware (without revalidation of the data)
  • Fully documented and validated processes

Learn more about our services ->

Less time spent on audits

Because processes are fully documented and validated, client audits are much less demanding for staff.

Less work, lower costs

Our customised solutions automate processes. This saves organisations a lot of work and results in lower costs. Would you like to know more about how we take GxP data governance to the next level? Contact us for an obligation-free consultation.

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