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.
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.
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.
A visibility platform designed for you
Built to reduce your workflow by bringing all shipments under one platform. SECURE’s flexible platform model lets you pick and choose modules based on your specific business needs.