As GxP systems move to cloud and SaaS models, cybersecurity risks are no longer limited to internal infrastructure. External exposure, third-party dependencies, and human factors now directly impact data integrity, product quality, and regulatory compliance.
With the revised EU GMP Annex 11 particularly Section 15 (Security), and the introduction of Annex 22, organisations are expected to demonstrate ongoing cybersecurity governance and assurance across the full system lifecycle—not just point-in-time controls.
Tech Qualitas supports this through a combined consulting and platform-enabled approach.
We help organisations manage cybersecurity for GxP systems through two complementary layers:
We act as an extension of your quality, compliance, and security teams to support:
To support ongoing assurance under Annex 11 Section 15, we provide access to a cyber risk monitoring platform that enables continuous visibility of external exposure relevant to GxP systems.
We work as an extension of your organisation, helping you remain secure, compliant, and inspection-ready as systems, suppliers, and threats evolve.
