21 CFR Part 11 compliance as well as compliance to the new requirements for Data Integrity
The WinDiss ARGUS Dissolution Software is a scientific dissolution data management software for instrument control, data acquisition, data management, processing and reporting – designed by users for users. WinDiss ARGUS Dissolution is compatible to almost all dissolution systems in the laboratory. Just one software needs to be trained and qualified. Whether you perform dissolution tests occasionally or several times each day WinDiss ARGUS Dissolution will make you more productive in running tests and analyzing results.
The WinDiss ARGUS Dissolution Software installed on the TIDAS ® L 520
WinDiss ARGUS Dissolution simplifies how you collect and report dissolution test results by letting you choose the analysis template that matches the way you work. Whether you are in QC concerned about data integrity, compliance and validation, or need maximum flexibility in R&D, WinDiss ARGUS Dissolution can help your lab perform more efficiently.
Example Test Report Dissolution Profile
Data Integrity, 21 CFR Part 11
Have data integrity and 21 CFR Part 11 compliance WinDiss ARGUS Dissolution allows you to multi-task without using multiple software packages. Maintaining regulatory compliance is easy with WinDiss ARGUS Dissolution. With the System Qualification Wizard you can schedule your next qualification tasks. Validation protocols covering software, spectrophotometer, baths and accessories are available for systems driven with WinDiss ARGUS Dissolution. WinDiss ARGUS Dissolution automatically creates detailed audit trails to record changes of methods, analyses, system configurations and other relevant data. Every entry is identified with the date and time of the modification together with the operator's name. Secure system authentication ensures that only authorized users are able to access the system. Permissions for each action can be combined into roles that represent method developers, system administrators, operators or whatever is required in your working environment.
Complete Data Management
Enhanced Data Management WinDiss ARGUS Dissolution manages all your data needs from instrument control to final reports, and makes your lab more productive.
It connects data and any modification applied afterwards with the identity of the operator using the computer system. It logs relevant events, errors or login failures Future-Proof TechnologyBuilt on industry standards, developed according regulations and guidance set forth in 21CFR Part11 and GAMP5, WinDiss ARGUS Dissolution is designed to be your versatile tool to manage your lab’s dissolution test workload while reducing your validation effort to a minimum.
Dissolution Calculations
WinDiss ARGUS Dissolution has already built-in calculations that corrects for volume changes and mass loss. With this all-in-one approach, time consuming and error-prone transcription of data collected from various sources into spreadsheets will be a thing of the past.
Flexibility
WinDiss ARGUS Dissolution can be used for all Pharma Test Dissolution Testers as well as for other brands. For more information refer to section "Specifications".
Drivers Currently Available
Instrument Category | List of Supported Instruments |
Drivers for Dissolution Tester | Pharma Test PTWS 120D/S, PTWS 820, PTWS 620, PTWS 1220, PTWS D620, PTWS 1420, IDS 1000, PT-DT8, PTWS 300, PTWS 310, PTWS 610, PTWS 1210, PTWS D610
Hanson SR8 Plus, Vision Elite & Classic 6, Vision G2 Elite & Classic 6 Sotax AT7/AT7smart, AT Xtend; Varian VK70XX Distek 2100, 5100, Evolution series ERWEKA DT800, DT700, DT720 Copley DT600, DT800 |
Drivers for Spectrophotometers
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Pharma Test TIDAS L, T70, SA500
Agilent 8453, 8454 Agilent/Varian Cary50 J&M Tidas II (9-channel fiber optic) AnalytikJena 200/205/210/250 Beckman DU800 Kontron Uvikon XL Cecil 2000/3000/4000/7000/9000 series PerkinElmer LAMBDA 2/20/25/35/45 Shimadzu UV1700 PharmaSpec, UV1800 Tec5 MultiSpec Thermo Evolution 300 Zeiss MCS5XX, MCS6XX(2-channel fiber optic) |
Drivers for Pumps | Pharma Test PT-SP6, PT-SP8
ISMATEC IPC/IPC-N Hanson AutoPlus MAXIMIZER, Vision G2 AutoPlus Hamilton Dynamix III Sotax CY-7-50, CP7 Varian Vk806 Watson Marlow 323Du Distek Evolution 4300 Solvias Micamix Dual Syringe |
Drivers for Dilutor Autosampler & Fraction Collector Driver | Pharma Test DSR-M, PTFC
Gilson 223 (Agilent G1811A) Hanson AutoPlus MultiFill, G2 AutoFill PerkinElmer AS90, AS93plus, S10 Sotax C613/C615 Varian Vk8000 Distek Evolution 4300 Valve Driver Hamilton MVP Rheodyne MX Series II Injector Drivers available on demand Agilent 8452A Beckman Du600 Distek 2230A PerkinElmer L265,365,465 |
The PTG-S5 comes ready to use with the following standard scope of supply: