Disso.NET 2018 Advanced Dissolution Software The highlights of the new Easy documentation with industry proven features The documentation features of the Disso.NET 2018 are vast: Easily gen-Disso.NET 2018 dissolution software erate reports about products, tests, audit trail, measurement conditions, UV-Vis and HPLC workflows and export data as PDF, XML and Excel format. The ERWEKA Disso.NET 2018 is the perfect 21 CFR Part 11 com-pliant companion to all our Dissolution Systems, ranging from Dissolution Offline over Online to On-/Offline Systems up to the fully automated RoboDis II system and the USP 4 Flow-through-cell Systems.* The software helps you with standard dissolution jobs, easily han-dles qualification tasks and provides control over each single function and connected devices (e.g. dissolution tester with UV-Vis spectrophotometer). After finishing those tests, Disso.NET creates extensive reports with corporate logos for PDF-file export or exports your results in XLS or XML. Our extensive Audit Trail according to latest 21 CFR part 11 thoroughly documents all changes done to the system (what, who, when and why) and can be easily searched and filtered by the Audit Trail Viewer. Supports Dissolution Systems, RoboDis II and USP 4 The Disso.NET 2018 supports all ERWEKA Dissolution Systems, the fully automated RoboDis II and even our USP 4 Flow-Through-Cell systems.* Full Audit Trail according to 21 CFR Part 11 NEW! The new Audit Trail feature is implemented throughout the whole software, tracking each and every change (What, Who, When and Why). If data is changed by the user (e.g. when editing methods), the software requires a reason entered by the user. In combination with our easily search- and filterable audit trail viewer, changes to the system and its data can be easily traced back to its origin and originator. With Disso.NET 2018, it is not possible to delete data from the system Full Audit Trail Support for according to USP methods 21 CFR Part 11 1, 2, 4, 5 and 6 Automated prompt for reason of change MS SQL User Database Management *Disso.NET 2018 with USP 4 support available Q2/2019 2 3 Disso.NET 2018 Highlights of the new Disso.NET 2018 From DT to RoboDis II Highly flexible Ful control for al our systems The main features of Disso.NET 2018 Disso.NET 2018 allows control over all our Dissolution Systems. Simpler Dissolution Online Systems, the low volume USP 4 Open and Closed Systems or the complex RoboDis II can all be controlled Easy data mangement by Disso.NET 2018 and reduce the device and system complexity to a few intuitive screens with a logic top to bottom approach. Users, methods, reports and more can be easily managed with Disso.NET 2018. Multi-user support with different user roles (Operator, Senior Operator, Administrator - all configurable) allow fine access control to the system and data and can be even fine tuned with single permissions. The automatic log off rounds up the access safety features and makes sure only approved personal have access. Dissolution Online System with UV/Vis (USP Meth. 1, 2, 5 and 6) System Suitability and Multitasking Constant system suitability tests ensure highest reliability by constantly checking the system. The JobController principle allows easy multitask-ing while testing. RoboDis II Fully automated Dissolution System (USP meth. 1 and 2) Documentation and Reports Disso.NET 2018 fully documents tests. By clicking a buttom custom-ers can easily generate reports with customized logos - from compact analytical reports to method data, calibration data or raw data. The integrated workflow allows easy approval and review before publishing reports for the paperless lab. Database with back-up and restore Our reliable and industry proven MS SQL database easily stores all your data - from methods to users, UV-Vis measurement data, reports and raw data. Additionally, easy to use MS SQL back-up and restore functions mean improved integrity and prevents loss of data! USP 4 Open and Closed System* Dissolution On-/Offline System Language support with HPLC or UV/Vis (USP meth. 1 and 2) Language support for English and German is already built into Disso.NET 2018. More languages can be easily added via language file. *Disso.NET 2018 with USP 4 support available Q2/2019 4 5 Disso.NET 2018 The highlights of the new - the main features of Disso.NET 2018 According to 21 CFR Part 11 Powerful modules Audit Trail The Disso.NET Editors Disso.NET 2018 features a comprehensive audit trail, tracking all All main features of the Disso.NET 2018 are located in separate changes throughout the system (what, who, when and why). When-windows, enabling a clear focus on the task at hand. These ed-ever an authorised user makes changes to any data on the system itors can be used to change media, edit filters and create new that needs to be tracked, an audit trail prompt appears and forces measurement, evaluation and medium preparation methods. the user to enter a reason for this change. Whenever data is created from scratch (e.g. a new method), the system automatical-Even for UV calculations, Disso.NET offers a unique interface spe-ly evaluates this audit entry and automatically adds a reason (e.g. cifically focused on its main task. “created”). All audit data can be comfortably searched and filtered using our new Audi Trail Viewer - allowing easy tracking of any change to Dissolution Editor the system with a consecutive audit number. This new feature complies to 100% to latest regulatory rules. The UI of our industry-proven Dissolution Editor has been refined for Disso.NET 2018 and now offers a clearer focus for the task at hand. Tracking What, Who, Comfortable Audit Trail When and Why Viewer for easy search Enforced Audit Trail - entering of data can not be omitted Audit Trail Viewer With the help of the Audit Trail Viewer, an authorized user can easily track all changes done to any audited data on the system. Qualifiying Tasks directly in the software ■ Semi-annual check of the photometer according to EP ■ Photometer qualification according to USP* Automated prompt ■ Daily check of the Agilent photometer ■ Temperature check of all sensors Whenever data that requires ■ Pump check audit is changed, a prompt ap- ■ Complete reports of qualifiying jobs pears and can not be omitted. *available Q1/2019 6 7 Disso.NET 2018 Audit Trail & The highlights of the new Dissolution features General features Different measuring methods ■ Sequences for several dissolution tests ■ Sample collection ■ Flexible measurement for calibration and control standards ■ UV/Vis and HPLC (System Suitability Test, SST) ■ On-/Offline measurement ■ Import / Export of XML method files ■ pH-change support* according to USP-Method A and B ■ Easy, flexible definition of measuring time points Online views ■ Automatic calculation of required pump time ■ Infinity test ■ Dissolution curve ■ Working with absolute & relative standard concentration ■ Measured absorptions and ■ Heater switch off after last run calculated concentration ■ Automated parameter check ■ Measured spectra, including ■ Log file with all information overlay ■ Simple time control ■ Timelapse functions* Sampling routine UV/Vis HPLC & sample collection ■ Optimized sampling routine ■ UV/Vis evaluation with ■ Precise withdrawn volume for low hydrodynamic different types of baseline cor- ■ HPLC injection parameters impact rection (single point, parallel adjustable in broad range ■ Emptying whole tubing translation, linear) ■ Flexible standard measure- during run possible ■ Recording of measuring ment for calibration & SST ■ Sampling tubes always parameters and individual ■ Media replacement down possible evaluation method ■ HPLC sample collection inde- ■ Automated inline filtration ■ Complete calculation/recalcu-pendent from HPLC lation of dissolution results ■ Support for Agilent, Waters, Shimadzu and more Report generation Report data UV-Vis report ■ Product name with batch-ID, method name, date and time ■ Measuring method ■ Measurement conditions, e.g. sampling time, media, temperature, ■ Calibration data rotational speed, filtration, etc. ■ Sample results overview ■ System configuration including dissolution curve ■ Customized logo ■ Overlay spectra HPLC reports Format and export ■ Withdrawn volume and time ■ Generation of reports in differ- ■ Documentation of all automatent formats ed working steps e.g. filling/ ■ Integrated paperless GMP measuring time of the sample workflow ■ XML, PDF, Excel ex-/import *optional hardware required for RoboDis II ERWEKA GmbH Pittlerstr. 45 E-Mail: sales@erweka.com 63225 Langen Phone: +49 6103 92426-200 Technical specifications of products described are stated without warranty and subject to change at Germany Fax: +49 6103 92426-999 any time without further notice. v.1.0.4.19