ISO 27001
ISO 27001 is the globally recognized standard for effectively managing information security. It offers comprehensive guidelines for establishing, implementing, maintaining, and continuously enhancing an Information Security Management System (ISMS).
The SECURE platform is ISO 27001 certified, providing enhanced protection of sensitive data, resilience against cyber threats, and compliance with regulations.
ISO 27001 fosters a culture of security, ensuring the confidentiality, integrity and availability of software and the data it handles.
ISO 9001
A quality management system that helps organizations be more efficient and improve customer satisfaction.
The SECURE platform is ISO 9001 compliant, demonstrating that it follows the guidelines, meets customer and statutory regulatory requirements and maintains documentation.
GAMP 5
Guidelines for manufacturers and users of automated systems in the pharmaceutical industry.
The SECURE platform is GAMP 5 compliant, following the set-out guidelines and goods practices in pharmaceutical computer systems.
21 CFR part 11
Rules which regulate the management and usage of electronic records in pharmaceuticals and medical devices.
The SECURE platform has implemented an FDA compliant digital Quality Management System using electronic records and e-signatures in place of paper-based documentation.
GXP
Regulations applicable to life sciences organizations and logistics suppliers that produce drugs, medical devices, and medical software applications.
The SECURE platform is GXP compliant, ensuring it’s safe and fit for use and meets the strict quality standards. Through using SECURE, logistics companies can achieve GXP certification.
The supply chain operating system designed for you
SECURE’s flexible modules lets you pick and choose modules based on your specific business needs.
