IDIS software for tablet and capsule dissolution testing has been developed as an open system to cope with the diverse range of analytical techniques required for USP Dissolution methods I, II, III and IV.

• Single user interface for all dissolution systems
  
  
• Automates most if not all dissolution tests
  
  
• FDA 21 CFR part 11 compliant
  
  
• Configurable, centralised, high level security
  
  
• SQL Database
  
  
• Local or client/server networking systems
  
  
• LIMS interface
  
  
• Easily manipulated, powerful, dynamic report editor
  
  
• Supports a wide range of dissolution baths, pumps, autosamplers, spectrophotometers
  
  
• Single or multiple systems per PC
  
  
• Support for open- and closed Loop systems using pumps or diluter/dispensers
  
  
• Collects and stores samples in autosamplers for online dilution, mixing and injection.

IDIS is a Client Server based system, integrating data from multiple IDIS data stations into a networked, relational database with central file locking capability.

Data and method records can be shared remotely by different laboratories for analysis and reporting using multiple field names with extended SQL querying.

System administration, creation and signing of reports etc can be performed remotely, requiring no physical access to the working laboratory.

IDIS software provides a single, generic user interface for virtually all dissolution hardware, which allows instruments from different manufacturers to be integrated into automated dissolution systems.

Using Solution Path Technology©, users can configure methods for different USP methods and perform multiple tests from the same IDIS workstation using different instruments.

This open system for Control, Data Acquisition, Calculations and Reporting also offers extended security and management features to comply with FDA.

All security settings can be remotely defined by an authorised administrator from any IDIS EE workstation.

Global Settings allow the administrator to set system limits to prevent unauthorised access to the data station.

Individual access to the system is governed by a unique User Name and Password. The user logon name, full name and password are configured for each user with group- or individual access rights for Log-on levels, Methods, Data and Reports. Password expiry, log-off times etc are configurable for each access level.

All entries and changes are recorded in a user queryable, printable Audit Trail.

IDIS can be configured to handle pre-run tests, baseline, standards (both before, after and during the run) and even on-line dilution and injection of collected samples onto HPLC systems.

Dissolution profile results are calculated and displayed graphically and numerically in real time with viewing and automatic update on both local and remote workstations.

The IDIS Report Organiser allows users to produce customised reports by selecting from a combination of objects such as Method Header, Data tables, Method parameters, Graphs and company logo.

Data can include any parameter measured during the run such as bath Temperature, Stirrer Speed, Time Intervals as well as Absorbance, Concentration,
% Dissolved.

Further items include Statistics and pass/fail reporting according to user definable compliance limits.

IDIS EE gives the administrator total management of the signing process from start to finish. This includes configuring the number of signing levels, users for each level and the signer activity and meaning. The signing order can also be defined.

Once results are produced in a group which requires signing, any report generated will show the signing status. Data records can be signed remotely on client stations

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