Sample Management |
File structure | Each sample sequence is embedded in a file, which contains all references for the analysis including control programs, integration methods, calibration information and reporting requirements. |
Sharing | Control programs, integration methods, calibration information and reporting requirements can be shared and are thus usable with any number of sample sequences. |
Data protection | Sample sequences are protected from accidental overwriting. |
Batch sequencing | Sample sequences can be linked together to run consecutively. |
Automatic shutdown | User-definable shutdown programs can be automatically started in a batch. |
Online interaction | Any manual interactions during processing of a sequence requires confirmation and is recorded. |
Control and Data Acquisition |
Instrument control | Control of one or two complete chromatography systems, full support for all Kontron Instruments and Biotek Instruments HPLC modules, control of other equipment via RS232 or relays. |
Data acquisition | Direct digital acquisition from diode array detector, analogue acquisition via A/D control card. |
Number of channels | Collection of data from maximum of 9 channels (6 analogue and/or 8 DAD chromatogram channels plus spectra). |
Free channels | Analogue channels may be defined as free channels to be started on independent time bases. |
A/D Control card | Six independent channels, 24 bit A/D conversion providing 1 µV resolution over the complete range from -1 V to +9 V, auto-calibration of A/D converter at the start of each run for maximum accuracy and reliability, each channel has its own synchronisation input for start of acquisition etc.
Six potential-free programmable relay outputs for control of external devices, e.g fraction collection. |
Programmable triggers | On-line peak detection for triggering control of fraction collectors or column switching in real time, control cn be based on level, threshold and time window. |
Integration |
Parameters | Integration parameters for peak detection are automatically optimised for each peak individually. |
Reprocessing | Chromatograms can be re-processed in either batch mode or singly, manual manipulation of baselines and peak markers with re-integration possible. |
Parameter control | Automatic control of parameters, e.g. Integrate inhibit, possible using a time-controlled parameter table embedded in the defined analysis conditions. |
Component identification | Using peak table with defined retention time conditions and windows for each component, with diode arary detection spectral matching is also possible. |
Grouping | Grouping of peaks in the peak table is supported. |
Chromatogram manipulation | Overlay, Zooming, Subtraction and Addition of chromatograms with factor definitions is supported. A chromatogram can be automatically subtracted during online batch acquisition. |
Spectral Handling |
Online display | Contour or 3-dimensional plot with freely selectable viewing angle and viewing distance, peak purity. |
Extraction | Mouse-controlled extraction of both spectra and chromatograms |
Spectra library | Creation of new spectra libraries is supported, search for component identification in different libraries possible. |
Peak purity | Online peak purity calculation with graphical display and spectra report |
Spectra index | Automatic extraction to store all significant information |
Lambda maximum | Lambda maximum function searches for optimum integration path |
Quantification |
Calculation | Based on either area or height |
Method | Internal, internal weighted and external standard are supported. |
Calibration | Linear or quadratic with or without offset, exponential. |
Multiple calibration | Using diluted or individually balanced standards, including bracketing. |
System Suitablity Testing |
System check | Automatic checking of selectable values, e.g. retention time, relative retention time, calibration etc. |
Statistics | Statistical evaluation of sample or standard sequences for a rapid overview of sequence quality. |
Control Charts | Graphical evaluation of values in a sequence, e.g. retention time |
Reporting |
Standard report | User-definable standard print-out |
Report manager | User-configurable report manager for designing custom reports via Microsoft Word, direct link to Word and export in batch mode |
Export | Direct export to Microsoft Excel is supported in batch mode, direct execution of macro-programs supported |
21CFR Part 11 Compliance |
Architecture | Client/Server architecture using one configuration for all connected clients |
User identification | System start is only possible with valid user log-in and password |
Password | Minimum length, maximum validity and minimum difference definable |
Access rights | Definition for each individual application function and user group |
Audit trail | Time of action, User name, PC workstation location, Importance level, Description of the action. |
Revision management | Comprehensive Document Management System for absolute traceability |
Electronic signature | For the levels Author, Quality Management, Review and Final, data sets can be locked after signing |
Database | Support for Microsoft SQL 7 or 2000 and Oracle versions 7, 8 and 9 |
All specifications may be subject to change for technical reasons. |
