Matrix Stability Express TK was designed in conjunction with several major Pharmaceutical companies to manage and report on protocol driven studies associated with stability or shelf-life testing. The protocol designer allows the entry and subsequent management of all study data. Furthermore, information is stored in one location for easy access by authorised users.

Matrix Stability Express TK also manages storage room operations for quick and easy retrieval of samples and the cycling of conditions, where required. An inventory management capability ensures sufficient material is available for an entire study and prevents undue wastage through the excess storage of containers. As samples are taken from a store room, information is automatically registered onto the results system and the appropriate tests and limits allocated according to the protocol requirements. This saves significant operator time and raises the efficiency of stability testing exercises.

Audit trail generation and other features assist in the compliance with FDA Regulatory Requirements such as 21 CFR Part 11.

Autoscribe offers a choice of two validation service plans:

1)     A set of tools that helps users validate the system using prepared documentation.

2)    A full validation service that involves visits to the user site for the execution of validation scripts.

Matrix Stability Express TK provides everything from protocol design and approval to completed trend plots and reports.

Modern Intuitive Graphical User Interface

The complex area of stability study management has been addressed to varying degrees by LIMS vendors. Often, stability systems are provided as "add-on" modules to commercial LIMS, providing little more than simple sample and test scheduling with very limited functions for the stability worker in areas such as planning, storage and inventory control.

Matrix Stability Express TK was designed as a standalone Stability Study Management module. However, many of the tables defined in Matrix LIMS are common to the Matrix Stability module thus ensuring that customers who also want to deploy a full LIMS system can fully integrate Stability Express TK with their LIMS system ensuring that key data only has to be entered once.

The configuration tools which may be also be supplied as part of a Matrix system allow users with no programming skills to further design screens and menus which best suit their applications.

The complete stability software system contains several modules:

Protocol Manager

Is used to create and maintain the details of conditions, pull periods and the tests to perform.

Study Maintenance Manager

Holds general information about the study, including description, cost centre and products. All entries and changes are under full audit control.

Batch Maintenance Manager

Holds blend, formulation/recipe, packaging and manufacturing details.

Location Manager

Contains storage conditions and locations for each sample entity (container, tablet, strip etc.) which can be specified by room, shelf and position.

Inventory Manager

Calculates the total number or amount of samples required for each study, before it is initiated. It accommodates retained samples and allows for replicates and sample re-use.

Reporting

Several standard reports are provided with the system including Protocol Report, Forecasting Report, Container Labels, Placement Report, Pull List, Summary Reports and Container Tracking Reports.

Any ODBC reporting tool such as Business Objects Crystal Reports can be used to generate further reports.

Sample Workflow Manager

Matrix Stability Express TK also contains a full Sample Workflow Manager that permits the manual registration of samples and results entry, validation and sample approval.

                                                                  Sample Release Workflow Management

                                     Manual Sample Registration

Please contact Autoscribe for further information.

Matrix Stability Express TK comes with a set of standard reports, together with detailed statistical analysis and graphics plus shelf life projections, accelerated shelf life and more.

Audit trail generation and other features assist in the compliance with FDA Regulatory Requirements such as 21 CFR Part 11.