Designed in co-operation with several pharmaceutical companies to manage and report on protocol driven studies associated with stability or shelf-life testing
Matrix Stability Express TK has been designed in co-operation 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 of all study data and subsequent management of all studies keeping all information in one easily accessible location for access by authorised users. Storage room operations are also managed to allow easy retrieval of samples and easy cycling of conditions where this is required. A comprehensive algorithm is used for inventory management that ensures that sufficient material is placed for the entire study and that no undue wastage occurs due to too many containers being stored.
As samples are pulled from the storage rooms they are automatically registered to the results system with appropriate tests and limits allocated according to the protocol requirements thus saving large amounts of operator time.
A set of standard reports is provided together with a link to the JMP software used for statistical and graphical analysis that may include shelf life projections or accelerated shelf life calculations.
The current release of Matrix Stability Express TK has many features to assist in compliance with regulatory requirements including 21 CFR Part 11.
Validation services are also offered with a choice of two plans.
The first is a set of tools that assists a user to 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.
