Particularly important to the pharmaceutical industry are software systems that improve efficiencies and provide traceability. Another key aspect to consider when choosing a system is the need to be in compliance to guidelines including FDA 21CFR Part 11 that requires change control, validation and audit trailing of changes to any stored data.
Matrix Gemini Stability Study Management
Matrix Gemini Stability helps to simplify the whole stability study management process, which can be complex and time consuming for multiple studies.
The fully configurable, built-in stability study management functionality is designed to automate and control the entire operation of the stability study including: protocol creation, study initiation and management, inventory management, sample pull points, future workload reporting and stability study reporting.
Environmental Monitoring
The Matrix Gemini Environmental Monitoring solution provides a robust framework for regular testing for contaminants at strategic locations such as air vents, bench tops and filling machines in production areas. The tests (and associated limits) and testing frequencies required for each sampling paoint can be defined. The system then uniquely links sampling point locations, test results and corrective action plans in one easy to use graphical environment.
Matrix Gemini LIMS for QA/QC & RnD
Matrix Gemini LIMS, with its unique set of configuration tools can be configured to support R&D and QA/QC laboratory testing regimes to help ensure ongoing product quality and to help meet regulatory compliance needs such as in Good Manufacturing Practice.
Raw materials and finished products can be tested against Master Record specifications and release mechanisms implemented for Batches and Lots. Defined workflows help ensure adherence to quality processes and full traceability of any actions carried out can be provided.
