New Release of Matrix Stability Data Management Software
Autoscribe are pleased to announce a new release of their powerful stability study protocol data management software for managing and reporting on shelf-life studies in FDA regulated industries. Sold either as a ‘stand-alone’ product as Matrix Stability Express or as an integrated module along with Matrix Gemini LIMS, this software provides a complete solution to the data management requirements in this demanding application.
The software provides for the design and approval of study protocols; calculation of the number of packages that must be placed into storage, based upon the testing protocol and package size; tracking on the placement of study inventory, its movement if required by the protocol and pulls for testing; scheduling of testing; entry of test results and production of final reports. These reports include:
q Study protocol report
q Batch report
q Condition report
q Placement report and sample labels
q Pulls required between specified dates
q Planned vs. Actual Pulls
q Audit reports
q Stability final report
This new release provides for a comprehensive audit trail on all study events, including multiple sign-offs on study protocols and prevention of changes (including deletion) to conditions already placed.
It also contains an intelligent counting algorithm for estimating the number of containers required to complete a study. Spare containers are now handled dynamically with required containers. After a study is approved and started, if testing is added to any future pull or additional pulls are added, the number of containers required is automatically deducted from the spare container count. If the requested changes would require use of more ‘spare’ containers than are in storage, the system alerts the user. Furthermore, the number of spare containers placed at the beginning of a study, may be expressed as a fraction of the required number i.e. 50% of the containers required for completion of the protocol.
The optional interface screen that allows selection of specific results in the Matrix database by study, condition, test and test attribute for analysis by JMP (SAS Institute) to calculate the predicted shelf-life and a special JMP script has been enhanced to allow for both single and double-sided confidence levels.
Matrix Stability software with these enhancements provides even more benefit to customers who may be “drowning” in paperwork and stand-alone spreadsheets while managing and reporting their stability studies, in compliance with FDA guidelines.
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Matrix Stability Data Management Software
Systems are fast to implement, less expensive to support, easy to upgrade and
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