Stability Study Management

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The task of managing pharmaceutical stability testing can be very demanding, especially on small to medium size companies developing and producing OTC, generics and new Rx products. Some companies outsource the actual inventory management and testing requirements, but they are still required to track progress and report results as part of their QA or development process. Ensuring that approved protocols are followed precisely, with "pulls" made on schedule and the appropriate tests completed, is a time consuming and tedious tasks.

It is for the exact above reason why Autoscribe Ltd., in collboration with two major multi-national pharmaceutical clients, has developed a "new generation" system, designed to comprehensively address the needs of an organisation involved in stability/shelf-life trials. Regulated environments such as the pharmaceutical, food/beverage and the consumer products industries together with relevant contract laboratories will welcome the comprehensive features included in this system. The "new generation" system named as Matrix Stability Express has been developed as the total answer to these needs.

Stability Study Management

Matrix Stability Express

Matrix Stability Express provides protocol and inventory management for studies where samples and associated tests are scheduled at specific time points, such as pharmaceutical stability testing, food shelf life studies and accelerated testing in material evaluation. In shorts, Matrix Stability Express does:

  • Simplifies study management from protocol design to graphical presentation of results
  • Optimises number of samples to be stored for study thus avoiding shortages and waste
  • Increses efficiency by full management of storage room operations
  • Saves staff time by automatically registering pulled samples with tests and limits
  • Minimises implementation time by use of included validation services
  • Provides fast presentation of results using standard test and graphical reports

On top of the above very good plus points, audit trail generation and other features assist in the compliance with FDA Regulatory Requirements such as 21 CFR Part 11 are included as well.