SmartGene has received certification in accordance with the requirements of the HDS Standard.
SmartGene recently achieved certification of its Management System under HDS by Bureau Veritas Certification France. As the result of an audit held in August, SmartGene's Management System was found to be in accordance with the requirements of the HDS Certification Referential version 1.1. - June 2018 Standard. The scope of the certification is as follows:
- PROVISION AND MAINTENANCE IN OPERATIONAL CONDITION OF PHYSICAL SITES TO HOST THE PHYSICAL INFRASTRUCTURE OF THE INFORMATION SYSTEM USED FOR HEALTH DATA PROCESSING
- PROVISION AND MAINTENANCE IN OPERATIONAL CONDITION OF THE PHYSICAL INFRASTRUCTURE OF THE INFORMATION SYSTEM USED FOR HEALTH DATA PROCESSING
- PROVISION AND MAINTENANCE OF THE VIRTUAL INFRASTRUCTURE OF THE INFORMATION SYSTEM USED FOR HEALTH DATA PROCESSING
- PROVISION AND MAINTENANCE OF THE INFORMATION SYSTEM APPLICATION HOSTING PLATFORM
- ADMINISTRATION AND OPERATION OF THE INFORMATION SYSTEM CONTAINING THE HEALTH DATA
- HEALTH DATA BACKUP.
SmartGene is also certified by Bureau Veritas according to the ISO/IEC 27001:2013 Standard.
This HDS certification for health data hosting is relevant for customers who are using SmartGene Applications in clinical diagnostics and builds upon SmartGene's ISO 27001 certification as well as SmartGene's established certifications under 21 CFR Part 11 and CE-IVD (In Vitro Diagnostic) labeling.
HDS Certificate number FR085864 (Health Data Hosting)