Pharma Test WinDiss ARGUS dissociation test data acquisition and control software is specifically designed for pharmaceutical quality control (QC), research and development (R&D), and dissociation testing laboratories. It can be used for fully automated control of various dissociation test systems, real-time data acquisition, drug release kinetic model fitting, and generation of professional regulatory reports. This software fully complies with international regulations and standards, including the United States Pharmacopeia (USP) <711/724>, the European Pharmacopoeia (EP) <2.9.3/4>, FDA dissociation test guidelines, US FDA 21 CFR Part 11 electronic records and electronic signatures, EU GMP Annex 11, and ALCOA+ data integrity.

I. Full architecture system compatibility fully supports offline (Offline DSR-M/pump), online (UV-Vis/HPLC/UPLC), dual-track integration (On/Offline), and in-situ fiber optic systems, enabling one-stop automatic scheduling and data connection.

II. Automatically performs sampling, dilution replenishment, evaporation loss correction and blank subtraction; built-in f1/f2 (or f₁/f₂) similarity factor calculation and multivariate dynamic release model fitting (Zero/First-order, Higuchi, Peppas, Weibull, etc.).

III. Strictly compliant with 21 CFR Part 11 and ALCOA+ provides multi-level access control, double electronic signatures, password security mechanisms, and a complete tamper-proof Audit Trail (recording timestamps, personnel, before and after values, and reasons for changes).

IV. Real-time dynamic monitoring and cGMP report output: Real-time dynamic plotting of multi-channel dissolution curves; one-click generation of standard cGMP PDF reports, and export of structured data in CSV, Excel, and XML formats, seamlessly connecting to LIMS/ELN systems.

Software Introduction

• Comprehensive Pharmaceutical Dissolution Automation Platform

  • One-stop workflow management: Specifically designed for pharmaceutical R&D, prescription screening, bioequivalence (BE) prediction of generic drugs and quality control (QC/QA) release design, integrating method establishment, instrument control, real-time data acquisition, automatic correction and compensation, release kinetics fitting to cGMP report output.

  • Fully compatible with original manufacturer hardware: Perfectly connects and controls the entire Pharma Test PTWS series of solvent dispensing systems (PTWS 130/630/820D/830/1230/D630/1420), TM/TMA automatic drug delivery modules, and the PT-DDS4 portable solvent preparation and dispensing system.

• Modular System Compatibility & Multi-Configuration Control

  • Offline System: Integrates DSR-M robotic sampling workstation or precision multichannel syringe pump (TMC) to support quantitative sampling, online membrane filtration, CAT-DM online automatic dilution (up to 1:100) and CAT-MRM equal volume/isothermal solvent replenishment.

  • Online UV-Vis System: Seamlessly connects to mainstream spectrophotometers such as Agilent Cary 60, Analytic Jena SPECORD, J&M TIDAS L, Cecil, and PerkinElmer, achieving zero dead volume real-time absorbance scanning and concentration conversion through a multi-channel flow cell.

  • Online HPLC/UPLC System: Directly controls the synchronous connection between the dissolution sampling end and the HPLC/UPLC autosampler (Valco valve) to accurately perform online real-time quantitative injection of multi-component, low-dissolution, or compound preparations.

  • In-situ Fiber Optics: Combining J&M TIDAS diode array (DAD) fiber probes, it performs high-frequency in-situ spectral acquisition within the dissolution cup at the second level, accurately capturing the ultra-early dissolution curves of the initial disintegration stage and the immediate-release prescription.

  • Online/Offline Integrated System: Simultaneous online UV-Vis rapid real-time monitoring and offline sample vial collection (for subsequent HPLC impurity analysis or backup testing) in the same step.

• Regulatory-grade automatic correction algorithm and BE similarity assessment (Regulatory Mathematical Correction & BE Assessment)

  • Multidimensional automatic mathematical correction: built-in sampling volume loss correction, isothermal solvent replenishment and dilution replacement, long-term evaporation loss correction, and automatic blank subtraction of solvent/additive background.

  • Bioequivalence comparison (f1/f2 factors): Compliant with FDA, EMA and ICH regulations, automatically calculates the difference factor (f1) and similarity factor (f2) and provides confidence interval calculation to quickly assess the in vitro release consistency between the test sample and the control drug (RLD).

  • Advanced Kinetics Modeling: Built-in one-key fitting, correlation coefficient (R²) analysis, and release mechanism determination for Zero-order, First-order, Higuchi, Hixson-Crowell, Korsmeyer-Peppas, Weibull, Hopfenberg, and Baker-Lonsdale models.

  • Complete statistical data processing: Automatically calculates the mean, standard deviation (SD), relative standard deviation (%RSD), maximum value (Max), minimum value (Min), and judgment results for each time point from 6 to 14 cups.

• Data Integrity and 21 CFR Part 11 Compliance

  • Multi-level access control: Built-in Administrator, Supervisor, Analyst, Operator multi-level permissions, with password complexity policies, periodic mandatory changes, error lockout and automatic logout when idle.

  • Double Electronic Signatures Workflow: Supports two-stage electronic signatures by Reviewer and Approver, which are legally binding and bind login credentials and the reason for signing.

  • Unalterable Audit Trail: The entire lifecycle of the audit trail is automatically recorded, including the establishment, modification, trial initiation, parameter changes, correction values, and manual intervention. It fully records the values before and after the change (Before/After), timestamps, and reasons for the modification. The logs are protected by system encryption and cannot be deleted.

  • Secure Database: All raw experimental data, spectrograms, and historical records are stored in the database with high-strength encryption, preventing file tampering and deletion at the operating system level.

• Intuitive monitoring, standardized reporting, and LIMS system integration (Real-Time Monitoring, Reporting & LIMS Connectivity)

  • Real-time dynamic graphical monitoring: The intuitive interface can dynamically display up to 14 channels of dissolution percentage curves, temperature of each cup, stirring speed and remaining time, and supports switching between multiple views of concentration graphs, absorbance graphs and raw data tables.

  • Standardized cGMP PDF report generation: Generate uneditable encrypted PDF inspection reports with one click, fully covering product batch information, method parameters, instrument serial number, point-by-point data and statistics (Mean, SD, %RSD), dissolution charts, and electronic signature fields.

  • Structured data integration with laboratory systems: Supports exporting test data to standard structured formats such as CSV, Excel, XML, and JSON, seamlessly integrating with Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), and ERP systems.

• System Compatibility & Validation Support

  • Wideband system and communication compatibility: Fully compatible with Microsoft Windows 10 / Windows 11 (32/64-bit Professional/Enterprise editions), supporting Ethernet (TCP/IP LAN), USB, RS-232 and high-speed CAN-Bus communication protocols.

  • Original Manufacturer Validation Kit: Includes a standardized original manufacturer Software IQ/OQ (Software Installation and Operation Validation) kit to help pharmaceutical companies quickly complete system validation at the installation site, fully meeting domestic and international regulatory audit requirements.