Biomarker Solutions

Computerized systems and IT security

Information is stored on an HCH modular Server System 3i7*.

System function: Intel-based multi-core Linux-Server with RAID-Storage. Server provides transfer and data storage functionality. The system is validated.

System storage: The computerized system is stored in an environmentally-controlled area, in a locked room in a special server room of the Biotech campus.

Virus protection: Virus protection and detection measures: Sophos Antivirus for Linux.

Access control: is specified: access control to the server in the server room, electronic locks at the entrance, key locks at the server rack and the server. The BBB management facility, which is managing the Biotech Park where Pharmaimage is located, operates its own IT system with all necessary safety protocols and firewalls. There is a written procedure for using and maintenance of the system. The BBB facility management has installed an uninterruptable power supply between the different buildings of Biotech Park.

Back-up storage: There are off-site back-up facilities for key documents and software. Those are readily retrievable.

Database archiving/administration: The electronic records are stored on the servers RAID while they are in use. Every day an incremental backup is made on an external HDD. A complete backup is made every week to second external HDD. For data administration of imaging and electrophysiological data as well as related meta data (quality parameters, sociodemographic and clinical data) the informatics platform XNAT is used. XNAT is an open source imaging informatics platform. XNAT´s core functions manage importing, archiving, processing and securely distributing imaging, electrophysiological and related study data ( For clinical trial management: XNAT CR -- is 21 CFR Part 11 compliant and tuned to the needs of FDA clinical trials.

*Alternatively, internet-based cloud services can be used for data storage and administration.


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