Stability LIMS

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, can be time consuming and tedious tasks.

Autoscribe’s Stability Study Management system offers start to end management of all types of Stability Studies within the busy food and health laboratories. Including work flows for sample storage and analytical testing, approval phases and importantly statistical analysis, and reporting. 

Built on our configurable Matrix Gemini software, Stability Study management is a comprehensive solution that can be configured to replicate the specific requirements for any laboratory.  Designed to comply with regulatory guidelines such as 21 CFR Part 11 the system includes full protocol design and sample inventory management. It may be integrated with Matrix plus LIMS for sample registration, testing and reporting. The complete system contains the following modules.

• Protocol manager is used to create and maintain the details of conditions, pull periods and the tests to be performed.
•  Study maintenance manager holds general information such as description, cost centre and products
• Batch maintenance manager holds blend, formulation/recipe, packaging and manufacturing details.
• Location Manager contains storage conditions and locations for each sample entity (container, strip, box etc.)
• Inventory Manager calculates the total number or amount of samples required for each study
• Reporting several standard reports are provided with the system including Protocol Report