| 21 CFR Part 11 Compliance |
| User accounts |
Access rights and passwords can be set-up (including parameters e.g., minimum length, validity, etc.). Each user can define the appearance of their own station. |
| Audit trails |
Selected events are recorded and can be reported either as part of chromatograms or in separate reports. |
| Electronic signatures |
All chromatograms can be electronically signed. Any changes to a signed chromatogram invalidate the signature. |
| Validation / Qualification |
Installation qualification (IQ) and operational qualifictaion (OQ) are available. |
| Instrument Control |
| YL Instruments |
Full control of YL9100 Series HPLC modules via high speed LAN interface. |
| Non-YL Instruments |
Control of numerous other HPLC and GC system modules via LAN, RS-232 or GPIB interfaces.
|
| Data Acquisition |
| Acquisition |
Simultaneous data acquisition from up to four independent chromatographs, each chromatograph can acquire data from up to 12 detectors. |
| Overlay |
Simultaneously displays of a virtually unlimited number of chromatograms and their mathematical modification; for example, mutual subtractions or derivations of any order. |
| Data Management |
| Integration |
Extensive possibilities to optimise integration. The integration parameters can be changed by entering global parameters or interactively, through direct graphic modification of the baseline. |
| Calibration |
Internal and external standard calculation methods, calibration of groups of peaks and reference peaks method for better identification. |
| Post-run |
Automatic display, printing, export and start of other programs after the completion of a run. |
| Custom calculations |
User can define custom calculations in the Result and Summary tables. Using the integrated editor you can create your own calculations from original columns and individual mathematical functions. |
| Add-on Modules |
| PDA extension |
Process data acquired from YL photo diode array detectors. The spectral data, together with chromatograms, adds a third dimension to analytical data analysis. |
| SST (System Suitability Test) |
Compares up to 12 selected parameters calculated according to one of three pre-selected methods (USP, EP, and JP). These calculated values are either compared to the user’s set limit values for each chromatogram separately or together for the selected series. |
| GPC extension |
Provides interactive and automated GPC analysis, including recalibration and GPC reporting, as well as simplifies the retrieval of GPC data |