ARGUS / Dissolution Version 2 - Dissolution Data Management Software
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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.
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
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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