Quality is at the heart of everything we do

Quality is one of VisMederi’s key strengths, recognised and valued by clients in Italy and worldwide. Our integrated Quality Management System (QMS) is designed to ensure data integrity, continuous improvement, and robust compliance across all activities supporting clinical trial studies. Through an independent Quality Assurance (QA) Department, we provide structured oversight of laboratory processes, equipment, personnel, data security, and partner interactions, ensuring consistency, traceability, and inspection readiness at every stage.

Our QMS operates in line with Good Clinical Practice (GCP) and complies with applicable Good Clinical Laboratory Practice (GCLP) guidelines. The current GCLP framework integrates both research and clinical aspects of Good Laboratory Practice (GLP) and incorporates relevant requirements from EMA GCP for clinical testing laboratories, 21 CFR Part 58 (GLP), OECD Principles of GLP, and 42 CFR Part 493 Clinical Laboratory Improvement Amendments (CLIA), reflecting our commitment to scientific excellence, operational control, and information security.

GCLP also guides the application of GLP and GCP principles to the analysis of clinical trial samples, supporting GCP objectives and ensuring the reliability and integrity of generated data.

In addition, our QMS is designed to comply with:

• ISO 9001, promoting continuous improvement and innovation while encouraging employees at all levels, from management to operations, to achieve quality objectives;
• ISO 27001 requirements, ensuring that cybersecurity, information management, and information protection systems are aligned with the highest standards;
• ISO 15189, supporting high quality standards and ensuring the managerial and technical competence of the medical laboratory throughout its activities, through to final customer satisfaction.

Through comprehensive SOP governance, equipment qualification and monitoring, specialised staff training, proactive deviation and change management, and a strong internal and external audit culture, we deliver reliable, well-documented results our clients can trust. Continuous improvement is driven through collaboration with sponsors, external experts, and regular audits, making quality not only a requirement but a competitive strength.