Software is designed in conjunction with pharmaceutical companies to manage and report on protocol driven studies associated with stability or shelf-life testing
Autoscribe announces the launch of Matrix Stability Express TK, a new software package designed in conjunction with several 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.
Stability Express 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.
Matrix Stability Express TK comes with a set of standard reports, together with a link to JMP statistical analysis software for calculating 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.
Autoscribe is offering a choice of two validation service plans.
The first is a set of tools that helps users validate the system using prepared documentation.
The second is 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.
