A professional SQL data base guarantees maximum data security and data integrity – User have no chance to manipulate the contents of the data base or to delete parts of it. The strict requirements of the FDA 21 CFR part 11 are met in fill scope.
Data base tools ensure automated data backup and long-term data archiving.
Our new UVS 3.0 client/server version regulates data access and user rights via the security groups of the domain. All workstations consisting of either Uvikon® or Specord® PLUS instruments store their acquired data on a central SQL data base server.
Data and results of all instruments in a group can be displayed and analyzed, whereas systems and data of other groups are not visible. Methods can be created and validated centrally and afterwards selectively released for a specific group by electronic signature.
Our new UVS 3.0
- Common user management (consolidated in groups).
- Common method data base (individual subsets for specific groups selectable).
- Data belonging to one group can be displayed and analyzed by any member of the group from any workstation.
- Data belonging to other groups are not visible.
- Audit Trail and acquired data are indivisibly linked in the data base.
- Data security guaranteed by SQL data base (manipulation prevented, automated data backup etc.) à the requirements in terms of data integrity are met in full scope.
- SQL data base server is administered and maintained by central IT.
You can download the detailed data sheet here:
UVS X – 21 CFR part 11
In addition to the features and benefits of our UVS spectrophotometry data system, the 21 CFR part11 compliant version UVS X includes an integrated user and rights management which meets the strict requirements of the FDA.
- Integrated user and rights management – administration of user and access rights.
- Fully consistent audit trail and revision management.
- Data security is fully ensured by embedding the data in a relational data base.
- Unauthorized data manipulation or deletion is detained.
- Automated data electronic export, linked to a specific electronic signature.
- Single wavelength measurement, also with calibration curve.
- Multiple wavelength measurement with calculations using data of different wavelengths.
- Wavelength scan with possible definition of calculations based on acquired data from the scan.
- Wellenlängen-Scans mit der Möglichkeit der Definition von Berechnungen basierend auf Messwerten direkt aus einem Scan heraus
- Kinetics (sequential measurement for fast kinetics or parallel measurement of up to 10 / 14 samples in case of slow kinetic reactions).
- Integrated report manager for professional report design and report templates.
- Fully GLP compliant by unique linking of method revision, acquired data, calculations and report in a relational data base already in the UVS version.
- Simple method creation.
- Automation of complex calculations.
- Professional report design.
- Integrated workflow management.