Introduction

The company’s current main product is its Tablet Dissolution software that is marketed worldwide by Icalis and its Distributors. In addition to the software, Icalis also manufacture laboratory instruments including Autosamplers, Pumps, Valves and other instrumentation for Dissolution analysis. Many of the worlds largest pharmaceutical companies such as GSK, Novartis, Pfizer, AstraZeneca, Elan and Solvay etc., have multiple installations of the IDIS EE dissolution software. Applications for a wider chemistry discipline are already planned as well as other instrumentation.
This document is intended to give an overview of some of the features and applications for the IDIS EE software.

Development Strategy

• Sound technical development staff
• Large international sales organisation
• The most comprehensive dissolution software available today
• Meeting the quality standards and Validation requirements of the pharmacy industry

Focus
to develop innovative automated solutions for the Chemical and Pharmaceutical industry which comprise both hardware and software

IDIS EE Design Target

• Automation of all Dissolution Tests for USP Methods I&II, III and IV
• Utilises existing Baths, Spectrophotometers and HPLC equipment in your laboratory.
• Unique detection using UV, HPLC Integration, Fluorescence and Conductivity
• Regulatory Compliance to 21 CFR Part 11
• Level of security over and above that of other dissolution systems.
• Truly open systems connectivity by dynamic linking of instruments Easily manipulated Report Organiser
• Data export option to LIMS
  

Typical system configurations

Solution Path - Closed Loop Peristaltic Pumping Configuration

Solution Path Open Loop – Diluter Dispenser Valve configuration diverting Sample to waste

Autosampler System with optional Dilution and UV Measurement

Autosampler Collection with optional Dilution and Injection into HPLC

Media Addition and Removal with optional pH Monitoring in each Vessel
Systems for Discrete or Gradient Media Addition can be configured with Media removal and multiple Media Change during the analysis.

FDA 21 CRF part 11 Compliance

The IDIS EE Administration allow the system administrator to enter details of users to access the system. The user Logon name, full name and password are configured for each user with Group or individual access rights.
Individual access to the system is by a unique user name and password and the users full name is displayed whenever the user logs on successfully.

Configurable Centralised Security

The Global Settings allow the administrator to set limits to prevent unauthorised access to the data station, Password expiry, Log Off Times etc for each access level.
These activities can be performed remotely from any IDIS EE networked workstation.

IDIS EE gives the user total management for signing, from start to finish. This includes configuring the number of signing levels, the Users for each level, Signer Activity and Meaning.

Signing and Reporting Signed Records

Once data is acquired in a Group with signing rights, any report generated will show the signing status for all records as shown below.

Dynamic Report Editor

The IDIS EE report organiser allows users to produce customised reports with the right information by selecting from a combination of objects such as Method Header, Data tables, Method parameters, Graphs and the company logo.
These details may include any parameter measured during the test such as bath Temperature, Paddle speed, Time Intervals as well as Absorbance, Concentration and % Dissolved. Any number of pages can be selected with automatic page numbering.

Standard Report Format Graphics Printer

IDIS EE is supplied with the Icalis Graphics Printer that provides compliance with 21 CFR Part 11 requirements for “human readable form”.
These reports can be circulated, emailed etc., in the safe knowledge that they are non-editable.

This Graphics Printer can capture any IDIS EE report into TIF, BMP or JPG (JPEG) and save them as electronic files.
The TIF format can save a multiple page report and the Image Viewer supplied automatically displays the printed file image for verification.

Networking

Our networked system provides a central relational database that contains all data (methods and data records) from all IDIS EE workstations. Details are accessible from any IDIS EE station linked to the networked database.
Each IDIS EE system runs from a workstation PC, as each hardware configuration can be unique.
This configuration allows Data records to be signed remotely by users from clients. For example, it is now possible for analysts and supervisors or managers to view, sign, print etc away from the laboratory area.

User Queryable Audit Trail

IDIS EE Audit Trail lists all user activity that creates, deletes or modifies; i.e., from logging on and off to editing of method and data records.
This Audit Trail can be queried to limit the volume of information from a search and the results from any search can be printed.