ARGUS / Dissolution Version 2 - Dissolution Data Management Software

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ARGUS / Dissolution Version 2 - Dissolution Data Management Software
ARGUS / Dissolution                                    Version 2

Dissolution Data Management Software

                             ARGUS/Dissolution Version 2 is a revolutionary scientific dissolution data management soft-
                             ware tool for instrument control and advanced data acquisition, management, processing
                             and reporting – designed by users for users.

                             Whether you perform dissolution tests occasionally or several times each day ARGUS/Disso-
                             lution Version 2 will make you more productive in running tests and analyzing results.
                                ARGUS/Dissolution Version 2 simplifies how you collect and report dissolution test re-
                             sults by letting you choose the analysis template that matches the way you work. Whether
                             you are in a QC department concerned about data security, compliance and validation, or
                             need maximum flexibility in the R&D area, ARGUS/Dissolution Version 2 can help your lab
                             perform more efficiently.
                                Intuitive wizards help anyone in your lab work better – your next dissolution test is run-
                             ning in just a few clicks.

Bringing You Faster to Reliable Results
•   Access dissolution data quickly using relational database technology
•   Correct turbidity in your spectra at a second wavelength or by second derivative
•   Analyze multi component drugs with models created by CAMO’s The Unscrambler
•   Drives spectrophotometers, baths and accessories of the market leaders
•   Controls oflline sampling, online measurement, fiber optics and even multiple baths systems
•   Allows seamless growth from single workstations to a dissolution laboratory network
•   Designed for a data-secured regulatory lab environment

                             ARGUS/Dissolution Version 2 allows you to multi-task without using multiple software pa-
                             ckages. You can acquire data and control a variety of instruments, including baths, pumps,
                             auto samplers and spectrophotometers. You can apply advanced calibration algorithms
                             such as MCA and PLS with an instant display of calculated data. You can deploy methods
                             and report templates for common use.
ARGUS / Dissolution Version 2 - Dissolution Data Management Software
Maximize Productivity
ARGUS/Dissolution Version 2 represents a fundamental
shift in dissolution software usability. With its unique
Analysis Tem-plate Technology, our software is designed
for every user in your lab – regardless of their task or
skill level.
    Use the Analysis Wizard to complete parameter sets
and run tests with minimal input or maximum flexibility.
You can navigate the entire environment from the ARGUS/
Dissolution desktop, including instrument control, a
real-time view of dissolution profiles, and a work area to
recalculate raw data or to create reports.
    Review your data without the need of creating reports.                Fig 2 Defining Roles in ARGUS/Dissolution
Data is displayed in a “What-you-see-is-what-
you-get” fashion known from standard office applications.
Additionally ARGUS/Dissolution provides a seamless inte-      Get More Information from Your Test
gration of the process of applying electronic signatures.     ARGUS/Dissolution Version 2 works with full spectra, pro-
                                                              viding more reliable detection of scattering and making
Exchange Data and Reports                                     multi linear regression models possible resulting in more
With raw data, methods and report templates stored            accurate multi-component analysis.
centrally within the same database, you can easily share
informationwith colleagues. Include only the details in       Dissolution Calculations
the report you want. Even the language of the report can      ARGUS/Dissolution Version 2 has already built-in calculati-
be chosen.Export data into CSV and JCAMP-DX format            ons that corrects for volume changes and mass loss. With
to feed your dissolution profiles and spectra into third-     this all-in-one approach, time consuming and error-prone
party software. Copy & Paste from ARGUS/Dissolution into      transcription of data collected from various sources into
your office applications.                                     spreadsheets will be a thing of the past.

                                                              Forge Your Automatic Cleaning Porgram
                                                              ARGUS/Dissolution Version 2 let you translate your expe-
                                                              rience with best cleaning procedures into a permanent
                                                              program. If the Hanson AutoPlusTM MAXIMIZERTM is
                                                              employed cleaning tubing and flow-through cells of an
                                                              online dissolution system with multiple baths is reliably
                                                              accomplished with a simple click.

                                                              Enhanced Data Management
                                                              From instrument control to final reports, ARGUS/Dissoluti-
                                                              on Version 2 manages all your data needs and makes your
                                                              lab more productive. No matter what type of lab you are
             Fig 1 Main screen of ARGUS/Dissolution           working in, you focus your time on science, not on data
                                                              transcription or file management.
Compliance                                                        The strength of ARGUS/Dissolution Version 2 is its
Maintaining regulatory compliance is easy with ARGUS/         reliability.
Diss lution Version 2. With the System Qualification          • It collects and stores test results, automatically linking
Wizard you can schedule your next qualification tasks.            system configuration and method parameter with each
Validation protocols covering software, spectrophotome-           dissolution test
ter, baths and accessories are available for systems driven   • It connects data and any modification applied af-
with ARGUS/Dissolution.                                           terwards with the identity of the operator using the
    ARGUS/Dissolution Version 2 automatically creates             computer system
detailed audit trails to record changes of methods,           • It logs relevant events, errors or login failures
analyses, system configurations and other relevant data.
Every entry is identified with the date and time of the       Future-Proof Technology
modification together with the operator’s name.               Built on industry standards, developed according to regu-
    Secure system authentication ensures that only            lations and guidance set forth in 21CFR Part11 and GAMP,
valid users are able to access the system. Permissions for    ARGUS/Dissolution Version 2 is designed to be your ver-
each action can be combined into roles that represent         satile tool to manage your lab’s dissolution test workload
method developers, system administrators, operators or        while reducing your validation effort to a minimum.
whatever is required in your working environment.                 Whether you need to control a single bath or support
    As a system administrator you can assign one or more      dissolution workflows that span the entire laboratory and
role to each individual user.                                 even offices, ARGUS/Dissolution Version 2 offers the right
ARGUS / Dissolution Version 2 - Dissolution Data Management Software
configuration for you. The database can run on a single         This configuration is designed for sample analysis by
work-station or on a server. You can easily add new clients     means of UV/Vis. Whether you withdraw your aliquots by
to both and migrate from a standalone system to a disso-        hand or automatically with an offline system ARGUS/Dis-
lution laboratory network.                                      solution Version 2 provides the appropriate counterpart
                                                                to continue your dissolution test workflow with only a few
Drive the Equipment That You Need                               clicks. Arrange sample sequences from various baths on
ARGUS/Dissolution Version 2 drives almost all dissolution       your xyz-auto sampler for unattended analysis. Spectra are
equipment of any vendor on the market. You can choose           automatically linked to your analysis dataset with instant
your favorite baths, pumps, spectrometers and accessories       calculation of dissolution values.
and build the dissolution system you need or advance
existing devices to automated systems at minimal cost.          Offline System
                                                                This configuration is designed for systems of one or more
Spectroscopy System                                             baths that do automated sampling into vials for offline
                                                                analysis by HPLC or UV/Vis. With AR-GUS/Dissolution
                                                                Version 2 you can drive your dissolution test system and
                                                                monitor stirrer speed, temperature, sampling, sampled
                                                                volume and other events required for an accurate calcula-
                                                                tion of dissolution results. You can easily process these raw
                                                                data into a report or add analytical data as they arrive.

                                                                Online UV/Vis System
                                                                This configuration is designed for unattended withdrawal
                                                                and analysis of samples which recently became indispensa-
                                                                ble whenever dissolution profiles are required or when the
                                                                throughput of your bath should be high even during the
                                                                night or on weekends.
         Fig 3 Spectroscopy System with XYZ-Auto Sampler

The Cutting Edge Application Software for Pharmaceutical
Dissolution Testing
Fiber-Optic System                                              Multiple Baths
This configuration is designed for in-situ analysis in the      Adding a second or a third bath to your dissolution system
vessel. ARGUS/Dissolution Version 2 copes with the              can be done with a minimum of fuss. Even if it is another
challenges of multi-channel fiber optic measurement and         make and model ARGUS/Dissolution Version 2 will simply
allows data collection rates limited only by the capabilities   incorporate it into the new configuration and reliably
of the spectrometer.                                            detect sampling time collisions - before the pill drops.

Data Client                                                     Analyze Combination Drugs in One Effort
This configuration is designed for in-situ analysis in the      You wish to analyze two or more active ingredients in one
vessel. ARGUS/Dissolution Version 2 copes with the              drug without the cost and time overhead of HPLC analysis
challenges of multi-channel fiber optic measurement and         but with maximal convenience and automation? ARGUS/
allows data collection rates limited only by the capabilities   Dissolution Version 2 has the chemometric power.
of the spectrometer.                                               You have the choice between multilinear regression or
                                                                even more sophisticated models like PLS created with the
                                                                well known CAMO The Unscrambler®.
                                                                   With the intuitive one-stop design of ARGUS/Disso-
                                                                lution Version 2 handling of these calibration models is
                                                                straightforward and as easy as applying common calibra-
                                                                tion types.

              Fig 4 Online Prediction with PLS2 Model
Enterprise Integration
                              ARGUS/Dissolution is based on the reliable ARGUS platform which seamlessly integrates
                              dissolution testing into your corporate environment, e.g. LIMS. Exchange methods and
                              analyses between development and QC laboratories. ARGUS/Dissolution is compatible to
                              your existing dissolution testers and also integrates additional hardware such as spectro-
                              photometers. The client-server architecture of the ARGUS platform perfectly fits into your
                              corporate network.

                                                               • ARGUS/Dissolution controls your dissolution tester
                                                                 hardware. Data is acquired from all devices you use in
                                                                 your dissolution test setup, including bath, spectrome-
                                                                 ter and pump. Methods and analyses are retrieved from
                                                                 and stored to the documents database.
                                                               • Connect multiple dissolution test laboratories to one
                                                                 central database
                                                               • ARGUS/Dissolution can be used off-line to query, re-
                                                                 view, approve, release and electronically sign methods
                                                                 and analyses.
                                                               • Use ARGUS/Dissolution to exchange data with your
                                                                 LIMS or enterprise document management system
                                                                 (EDMS).
                                                               • Query or browse methods, analyses and other data by
                                                                 using any standard webbrowser.
                                                               • ARGUS/Dissolution runs on a Java Virtual Machine
                                                                 which makes the application secure and extremely
                                                                 stable as required in highly regulated GxP environ-
                                                                 ments. With the ARGUS Software Deployment Server
                                                                 centralized deployment and version control is easily
                                                                 accomplished.
                                                               • If you are already running the stand-alone version of
                                                                 ARGUS/Dissolution migration to an enterprise version
                                                                 is always possible. All data (methods, analyses, …) can
                                                                 easily be transferred.

Features
Usability                                                      •   A11
•   Wizard access to major functions                           •   Concentration curve
•   Full keyboard control                                      •   Multi Component Analysis
•   Tooltips and context sensitive online help                 •   CAMO The Unscrambler model support
•   Document search capabilities                               •   Recalculation of analyses
•   Analysis template technology                               •   Statistics (pH, temperature, dissolution)
•   Emergency stop capability                                  •   Infinity test
•   English and German user interface                          •   Automated media change
•   Detection of possible timing problems
•   Real time dissolution profiles                             USP and Pharm. Eur. Acceptance
•   Customizable report templates                              • One or more Q-values for each API
•   ”WYSIWYG” method- and analysis display                     • High/low dissolution boundaries
•   Raw data export (Excel or JCAMP-DX)                        • USP S1, S2 and S3 testing in one record
•   Power and lamp saving functions
•   Multiple bath configurations                               21 CFR Part 11
•   Programmable cleaning procedures                           •   Detailed audit trail for electronic records
                                                               •   System log for tracking application events
Analytical Capabilities                                        •   Electronic signature support
•   Full spectrum support                                      •   Cryptographical record protection
•   Peak picking on all spectra charts                         •   Role specific access to program functions
•   Savitzky-Golay second derivative                           •   IQ/OQ/PQ support with reminder function
•   Turbidity baseline                                         •   Built in system suitability check
•   Placebo effect elimination                                 •   Failsafe technology for data recovery
Groupware Functionality (Enterprise Edition)                Autosampler & Fraction Collector Driver
•   Method deployment via shared database                   • Hanson AutoPlus MultiFill; PerkinElmer AS90, AS93plus;
•   Centralized user account management                       Sotax C613/C615; Varian Vk8000; Distek Evolution 4300
•   Prepared for LIMS connectivity
•   Review Data from different clients                      Drivers available on demand
                                                            • Agilent 8452A; AnalyticJena SPECORD 200/205/210/250;
Spectrophotometer Driver                                      Beckman Du600; Copley Scientific Dissolution Tester;
• Agilent 8453; Beckman DU800; Kontron Uvikon XL;             Distek 2230A
  PerkinElmer LAMBDA 2/20/25/35/45; Pharma Test
  SA500; Shimadzu UV1700 PharmaSpec; Tec5 MultiSpec;        System Requirements
  Thermo Evolution 300; Tidas II (9-channel fiber optic);   • 256 MB RAM recommended minimum
  Varian Cary50; Zeiss MCS5XX (2-channel fiber optic)       • 200 MB hard disk space recommended minimum
                                                              (includes space required during installation)
Dissolution Tester Driver                                   • Intel® Pentium® III or compatible at 800 MHz or better
• Hanson SR8 Plus; Pharma Test PTWS/IDS1000;                  (single core)
  Sotax AT7/AT7 smart; Varian VK70XX; Distek 2100, 5100,    • CD-ROM drive (only for installation)
  Evolution series; ERWEKA DT800                            • High-resolution monitor (1024x768 or higher, 256 colors
                                                              or better)
Pump Driver                                                 • Mouse or other pointing device
• Hanson AutoPlus MAXIMIZER; Hamilton Dynamix III;          • Serial port, PCI slot, ethernet port (the number of ports
  ISMATEC IPC-N; Sotax CY-7-50; Varian Vk806; Watson          needed depends on the instruments used)
  Marlow 323Du; Distek Evolution 4300                       • Microsoft® Windows® 2000, XP or Vista
                                                            • Adobe® Acrobat® Reader (to view manual)

Get a Free Demo
                            More details on ARGUS/Dissolution, a list of supported instruments and sample reports are
                            available for download at our website www.solvias.com.
                               To receive a free demo disc or to contact a product specialist send an e-mail to
                            software@solvias.com or ask your system vendor.
Solvias AG
       Römerpark 2
    4303 Kaiseraugst
         Switzerland

Tel. +41 61 845 60 00
Fax +41 61 845 69 00
     info@solvias.com
     www.solvias.com
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