Quality

Siena Imaging is certified to ISO 9001:2015, ISO 27001:2022, ISO 27017:2015, ISO 27018:2019 by Bureau Veritas Certification. SI operates in compliance with Good Clinical Practice (GCP) and Good Automated Manufacturing Practices (GAMP 5). Due to its activities for pharmaceutical companies, it possesses a quality system that integrates the world of ISO with the aforementioned guidelines to ensure patient safety and data reliability. It has a computerized system validated according to GAMP 5 guidelines for data management from input to release.

About Siena Imaging

Siena Imaging is internationally recognised for its commitment to excellence, innovation and quality. Thanks to our advanced technologies and dedication to continuous improvement, we have obtained numerous certifications that testify to our expertise and reliability in the medical imaging sector.

Certifications Achieved:

This certification attests that our quality management system meets the highest international standards, ensuring that our products and services are designed and manufactured with a constant focus on quality and customer satisfaction.

Siena Imaging is certified for information security management, ensuring that sensitive data is protected in accordance with international best practices. This certification underlines our commitment to maintaining data confidentiality, integrity and availability.

This specific cloud computing security certification ensures that our cloud-based services meet stringent security standards, protecting our customers‘ and patients’ information from threats and vulnerabilities.

Siena Imaging adheres to international standards for the protection of personal data in the cloud, ensuring that sensitive data is handled with the utmost care and compliance, particularly with regard to personally identifiable information (PII).

Compliance with Good Practices:

Good Clinical Practice (GCP)

We operate in accordance with Good Clinical Practice, ensuring that all our activities are conducted to the highest ethical and scientific standards, with the aim of protecting patient safety and data integrity.

Good Automated Manufacturing Practices (GAMP 5)

Our system is validated according to the GAMP 5 guidelines, ensuring that our automated processes are secure, reliable and compliant with current regulations, with a special focus on data management from acquisition to final release.

Quality and Safety at the Centre:

Thanks to our quality management system, which integrates rigorous ISO standards with GCP and GAMP 5 guidelines, Siena Imaging ensures solutions that put patient safety and data reliability first. This approach allows us to operate safely and efficiently, offering products and services that meet the most stringent requirements of the pharmaceutical and healthcare industries.

Awards and Certifications

Siena Imaging wins awards: Siena Imaging among the 100 most competitive and virtuous companies in Central Italy

Download the certificate here