ISO 27001:2022 Certified
Security at Aligned
At Aligned AG, we know that security is paramount. Hundreds of medical device manufacturers rely on us to protect their information, and we take this responsibility with the utmost seriousness.
We meet global security standards
GDPR/DSVO
Aligned AG is GDPR and DSVO compliant ensuring the required level of protection for personal data.
Our processes are aligned with Swiss and European data protection regulations, facilitating smoother operations across borders.
ISO 27001:2022
An ISO 27001 certification shows that Aligned AG has implemented structured processes to manage risks related to the security of data that Aligned owns or handles, and that these processes follow the best practices and principles defined by the international standard.
FDA 21 CFR Part 11
The Aligned products are designed to support compliance with FDA 21 CFR Part 11. The platform includes technical controls for secure user authentication, role based access control, e-signatures and audit trails that ensure electronic records remain reliable and traceable.
Data Security
Secure Development
Aligned follows secure software development practices to protect the integrity of the platform, including controlled access, multi-layered verification, and security checks throughout the development lifecycle.
We regularly perform independent penetration testing to identify and address potential vulnerabilities.
Secure Access Control
Our products implements secure access controls through robust FDA 21 CFR Part 11 compliant user authentication, a multitude of security settings including optional 2FA.
Aligned supports single sign on (SSO) integration with Microsoft Entra, giving organizations flexible and strong control over who can access the system.
Secure Deployment
Aligned offers secure SaaS deployment with each customer hosted on a dedicated server, completely isolated from other customers.
Each customer also freely choose the geographical location of their system, ensuring data residency and compliance requirements are met.