Stability Express Features

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In Matrix Stability Express, all features can be configured using an extremely elegant suite of configuration tools which allow appropriately authorised users to modify or create screen forms, menus and reports to suit individual end-user requirements:

  • Flexible study and batch inter-relationships
  • Configurable descriptive fields, free text notes and numbering schemes
  • Configurable review and approval systems
  • Copy, modify functions and use of study templates
  • Storage inventory calculation, prediction and monitoring
  • Condition cycling
  • Forward planning including "what-if" scenarios
  • Study activation, suspension & termination auditing
  • Storage operation management including auditing of container placement, moves, relocation, staging, pulls and scrapping
  • Automated or manual regstration of samples into LIMS
  • Reports and labels auto generation
Stability protocol design and storage room operations

Protocol design & Storage room operations

Matrix Stability Express has a protocol designer wizard that allows information concerning the study such as the purpose of the study, the study director, location, product, etc to be stored. Each study can have multiple batches with multiple conditions upon each batch. And each batch may be initiated on a different date from a different production batch, with different raw material suppliers or may be required because of packaging or dose changes.

Matrix Stability Express provides comprehensive management of stability storage room operations. Each protocol contains a planned start date for each batch as well as the placement date and any cycles or moves required. The system stores the exact location of each batch at every condition, room, chamber, rack, shelf, box etc. All actions such as placements, pulls, moves, cycles, relocations and scrapping are recorded with the actual time, date and ID of the person completing the action.

Worklists may also be generated for storage room staff that show what tasks are required during the period.
Stability Inventory Control Management

Inventory Management

Matrix Stability Express also contains an algorithm that calculates the number of sample containers of each batch that must be placed at each condition in order to execute the protocol.

This greatly assists in assuring that there is enough material in storage to complete the study, without generating large amounts of waste. The algorithm takes into account many factors such as the number of pulls, the amount of sample in each containers, the amount required for each test, if replicates can be performed on the same sample and much more.
Stability test result recording

Recording Test Results

The system contains a results database where the test results for each batch, condition and time point are entered. Limits can be set up for each test at each condition/time if that is needed. The values from testing are entered into the system manually via an easy to use spreadsheet format or matrix.

This database has full audit trail such that if any value is changed once it is stored, the original value is not lost, but stored before the new value is accepted. The identity of the person making the change, the time/date and reason for the change are recorded along with the new value. Historical versions of all results are readily available for investigation.
Stability Express Statistical reporting

Reporting

The system is supplied with several standard reports that include the protocol and batch status, placement and pull lists, tests required, summary reports that include test results to date and an OOS report. All these are created using a seamless integration with Crystal Reports. Reports may be exported in many different formats including Excel, Word, HTML, XML, CSV and more for inclusion into other documents.

In addition to printed reports, Matrix Stability Express also able to integrate with JMP for statistical analysis, which may include shelf life projections or accelerated shelf life calculations using the Arrhenius equation. All the plots and graphs can be stored and integrated into other documents for final reports.