A system that stores data, especially when used for e.g. healthcare data, has to be be reliable and safe.
Reliable The T&S data management system has been since the start in 2009 for 100% of the time accessible (a unique uptime of 100%). The DMS software is developed using a object-orientated high-level programming language. Compared to standard web programming languages this makes the source code not only very efficient but it also decreases the number of ‘bugs’ significantly and improves security, speed and reliability.
Secure All data are stored in a secure and fully certificated datacenter. NEN7510: data quality, integrity and confidentiality of healthcare data is guaranteed. ISO 9001, 14001 and 27001:2013. An information security management system (ISMS) according ISO 27001:2013 guarantees availability, integrity and confidentiality of data and information. Redundant fiber backbones to for example the two largest internet exchanges in the world: AMS-IX (Amsterdam) and DE-CIX (Frankfurt). Sensible data as for example passwords are stored encrypted. All data transfer with the system is encrypted.
Validated Fully validated including a safety analysis, and therefore it does what it should be doing. After every (major) update a new validation is done.
21 CRF 11 compliant The system is 21 CRF 11 compliant. This implies that e.g. electronic signatures, as used in the system, are as valid as hand written signatures.
GCP (Good Clinical Practice) compliant This implies e.g. that it is always known who did what when. GCP compliance implies that the system can be used for clinical studies.
GDPR compliant We care about privacy. The system is compliant according to the EU General Data Protection Regulation.