AIBILI-Association for Innovation and Biomedical Research on Light and Image

ABOUT USGI

AIBILI is ISO 9001 certified for the activities of: Performance of Clinical Studies; Planning, Coordination, Monitoring of Clinical Research Activities, Pharmacovigilance, Pharmacoepidemiology and Pharmacoeconomics, Grading of Eye Exams, Research and Development in New Technologies for Medicine in the areas of Imaging, Optics and Photobiology and Data Centre activities.
AIBILI Data Centre is certified by ECRIN Data Centre requirements.

SERVICES

Integrated Management System management and continuous improvement
Internal auditing and assurance activities
Risk-based improvement and corrective actions
External Quality Assurance (QA) and regulatory compliance consultancy
Training on quality and regulatory requirements

The Integrated Management System Unit (USGI) is responsible for the management, maintenance, and continuous improvement of AIBILI’s Integrated Management System (IMS), ensuring compliance with quality, regulatory, and ethical requirements.

The IMS is aligned with ISO 9001:2015, the Principles of Good Clinical Practice (GCP), ECRIN Data Centre certification requirements, and applicable European regulations, including GDPR (EU) 2016/679, Regulation (EU) No 536/2014, and Regulation (EU) 2017/745. ISO/IEC 27001 has been under implementation, strengthening information security, cybersecurity, and privacy.

The IMS supports all activities through a process-based and risk-based approach, regular internal audits, and continuous support to operational units, promoting compliance, efficiency, and continual improvement. The fully digital IMS ensures traceability, streamlined approvals, and audit-ready records.

https://www.sgs.com/en/certified-clients-and-products/certified-client-directory
https://ecrin.org/data-centre-certification

The USGI ensures that the IMS remains effective and efficient, with adequate resources to meet the needs of clients and stakeholders. In addition, the USGI provides external Quality Assurance (QA) services, delivers internal and external training on quality and regulatory requirements.

The USGI has a Personal Data Privacy Committee, responsible for promoting compliance with applicable personal data protection legislation, raising awareness, advising on the implementation of data protection standards, and monitoring compliance within AIBILI.

The USGI includes a Compliance Committee responsible for compliance with the Portuguese General Regime for the Prevention of Corruption (RGPC), which comprises managing and processing whistleblower breach reports submitted through the internal channel available at www.aibili.pt. The Committee is also responsible for elaborating and monitoring the Gender Equality Plan (GEP).

In addition, the USGI has a Data Access Committee, responsible for evaluating data access requests to AIBILI for the re-use of data in scientific research.