WinDiss ARGUS Dissolution Software

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WinDiss ARGUS Dissolution Software

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 labs 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

 

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



Features
  • Connect multiple dissolution test laboratories to one central database
  • ARGUS/Dissolution can be used offline to query, review, approve, release and electronically sign methods and analyses.
  • Use ARGUS/Dissolution to exchange data with your LIMS or enterprise document management system (EDMS).
  • Database Compatibility
    • MariaDB
    • MySQL
    • Microsoft SQL Server
    • Oracle
  • Additional USP/EP compliance features:
    • One or more Q-values for each API
    • High/low dissolution boundaries
    • USP S1, S2 and S3 testing in one record


Advantages
  • Instant recording of raw data
  • Standard database backup and recovery procedures
  • Long term persistence in XML
  • Detailed audit trail for electronic records
  • System log for tracking application events
  • Electronic signature support
  • Cryptographical record protection
  • Role specific access to program functions
  • IQ/OQ/PQ support with reminder function
  • Built in system suitability check
  • Failsafe technology for data recovery
  • Full Spectrometer OQ (as outlined in USP38)
  • Groupware Functionality (Enterprise Edition):
    • Method deployment via shared database
    • Centralized user account management
    • LDAP authentication (ActiveDirectory)
    • Prepared for LIMS connectivity
    • Review Data through your web browser

Included in the Standard Scope of Supply

The PTG-S5 comes ready to use with the following standard scope of supply:

  • PTG-ER automatic stirrer
  • Integrated clear view dust protection hood
  • Integrated Sartorius balance cell
  • Poring nozzles size 6, 8, 10, 15, 25mm
  • 600ml beaker
  • 30˚ angle calibration cone (calibration certificate optional)
  • Comprehensive documentation folder including:
    • User manual
    • DQ/QC instrument compliance test certificate
    • IQ documentation
    • OQ documentation
    • Instrument logbook
    • Compliance certificates for vessels and stirring tools




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