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).
SkyCell 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.
SkyCell 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.
SkyCell 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.
Skycell 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.
Skycell 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.
EcoVadis
SkyCell received the EcoVadis Gold Medal for continued development in Corporate Social Responsibility (CSR). This rating analyzes the topics of environment, ethics, labor, and sustainable procurement. In these four topics, our policies, actions, and results were assessed.
SkyCell received 77 points and is therefore classified in the top 1% of all the companies assessed by EcoVadis. Our goal is to increase our score even further by advancing our sustainability management system in line with our growth.
