Facilities and Software Systems
Our central facility was designed to provide building security and efficient process flow as well as an environmentally friendly work space. We took occupancy of the building in January of 2010 following a two year design and construction phase. Design input was gathered from sponsoring company auditors, IT professionals, geothermal heating experts, and structural engineers. The building was financed by a federal SBA 504 loan which required the building structure to meet wind and earthquake standards. The facility is supported with a natural gas generator and UPS power designed to provide an uninterruptable working environment for clients and staff. An internal monitoring system monitors and generates various administrative alerts for numerous facility parameters including data center environmental data, generator status, UPS status, as well as numerous network and server parameters.” Commercial 24/7 independent security and fire monitor services compliment real time internal monitoring.
Our state-of-the-art computing system is designed to support clients and staff 24/7. Wherever possible, single points of failure have been eliminated with replication, fault-tolerance and duplication of hardware. Virtualized servers run on the latest deployed name brand hardware chosen for its functionality and reliability. Since protecting the confidentiality and integrity of client data is one of our highest priorities, it resides on a central mass storage device that is continuously backed up to QST owned hardware located in a commercial data center remote to the QST central facility. In addition to the real time backup, tapes backups are performed regularly and stored off-site.
The software chosen to service our data management, statistical analysis, report writing, and eCTD compilation utilizes the best commercial software solutions that have proven track records within the industry. We continually evaluate our standards to comply with 21 CFR §11 through careful selection and integration of hardware, software, process development, SOP’s, and training.
- Statistical Analysis Systems® (SAS)
- TELEform data capture system
- Microsoft Office applications
- Adobe Acrobat®
- ClinPlus® Data Management System
- Merge eClinical OS Electronic Data Capture System
- eCTDBuilder® Datafarm Inc.