Autoscribe has released its stability data management software for managing and reporting on shelf-life studies in FDA-regulated industries.
The software is sold as a standalone product as Matrix Stability Express or as an integrated module along with Matrix Gemini LIMS.
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: study protocol report; batch report; condition report; placement report and sample labels; pulls required between specified dates; planned vs actual pulls; audit reports and stability final report.
The 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 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.
The number of spare containers placed at the beginning of a study may be expressed as a fraction of the required number.
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 JMP script has been enhanced to allow for single- and double-sided confidence levels.
