HPLC - UV/VIS Spectroscopy
Fibre Optic and Diode Array Applications
Software - Fluorescence
| Overview | Specifications | Ordering Information | Print Version | Documentation |
The UVSX 21CFR Part 11 compliant software is available as an option for the UVIKON XS and XL spectrophotometers.The software supports all common UV/VIS methods including both multiple activity calculations within a run and multi-wavelength kinetic capabilities using an automatic cell changer.
The possibility to include control of external autosamplers for fully automated analysis of large batches of samples is also available and can be configured to suit the type of sampler and customer requirements.
High Security Level
Only Administrators have access to the security settings for Options, Backup and Login. The software automatically checks for serial number and instrument type at every start-up. Group definitions allow data to be filtered for display according to the logged-on users.
Fully compliant with 21CFR Part 11 Rules
Access rights and user permissions are defined by the administrator in a controlled security area. Methods and acquisition reports are maintained under strict revision control. Configurable audit trail for complete history tracing including a deleted report trail.
A statement covering all aspects of the compliance with the requirements of 21CFR Part 11 is available by following the documentation link above.
Electronic Signature
Reports can be formally signed with an electronic signature provided appropriate rights have been assigned. Once signed the report is frozen and cannot be modified as required under 21CFR Part 11 rules. All signed reports carry appropriate labels on any printed documents for easy identification.
| Available Methods | ||||
| Fixed Wavelength | Data in AU, %T or concentration with factor | |||
| Wavelength Program | Data acquisition at between 2 and 14 wavelengths at high slew speeds. | |||
| Wavelength Scan | Acquisition of spectra | |||
| Time Drive | Acquisition of kinetic data over user-defined time intervals | |||
| Auto Rate Assay | Acquisition of kinetic data for multiple samples using a cell changer, measurements within the same run but at different wavelengths are also supported. | |||
| Calculation modes | Enzyme activities with regression, calibration, curve factors, derivatives, wavelength ratio, wavelength differences, blank subtraction | |||
| Other Functions | ||||
| Cursor | Selectable cursor for curves with real-time display of co-ordinate values | |||
| Zoom | Zooming permanently active in curve displays via mouse | |||
| Peak detection | Peak detection for peaks, valley or both, selectable threshold and sensitivity | |||
| Security Functions | ||||
| System access | Only users with administrator rights can access the system security settings for defining users etc. | |||
| User access | Password and User Name are required to log onto the system. Individual user rights must be first defined by the administrator | |||
| Groups | Users may be assigned to groups by the administrator. Users within a group have access to all data generated by that group. | |||
| Revision control | All methods and reports are maintained under strict revision control | |||
| Audit trail | Configurable audit trail tracks all events including deleted reports | |||
| Electronic signature | Reports can be signed by users with the assigned rights, e.g. approval. These reports are then locked and cannot be changed. | |||
| Hardware Requirements | ||||
| Processor | Pentium III or better | |||
| Memory | 256 MB RAM, min. 10 GB Harddisk | |||
| Operating system | Windows NT 4.0 SP6, Windows 2000 SP4 or Windows XP | |||
| All specifications may be subject to change for technical reasons. | ||||
| UVSX-01 | UVSX 21CFR Part 11 Compliant Software for UVIKON XS and XL |