Tech Qualitas helps life sciences and regulated technology companies stay compliant after go-live, as systems, suppliers, and release models evolve.
With the revised EU GMP Annex 11, including increased focus on cybersecurity under Section 15 and the introduction of Annex 22, organisations are expected to demonstrate not just controls, but ongoing governance, accountability, and evidence across digital systems.
We support organisations where validation, quality, and cybersecurity must work together, not in silos.
We help organisations maintain inspection-ready systems throughout their lifecycle
Aligned with Annex 11 expectations, we help translate cybersecurity activities into defensible GxP controls
We work as an extension of your quality and compliance function, helping you remain compliant as your systems—and risks—change.
Deep experience across QA, IT, Security, and Leadership
Practical interpretation of evolving regulatory expectations
Focus on continuity, not one-time projects
Designed for real operating environments
Schedule a consultation with us to discuss your quality and compliance needs. We’re here to answer your questions and explore how we can support your organization.
Founder
