Pharmaceutical LIMS & Stability Study Management
Managing QC testing in the highly regulated pharmaceutical manufacturing and tracking raw ingredients to final product has never been so easy.
Pharmaceutical LIMS Defined by Standards
Designed specifically for regulated manufacturing industries such as pharmaceutical manufacturing, Matrix Gemini Pharmaceutical LIMS is ideal for highly regulated industries working to standards such as FDA 21 CFR Part 11, ISO 17025 and cGxP.
Developed according to our ISO9001 accredited quality system the solution is supported by comprehensive validation documentation providing a head start to validation activities. Unique graphical configuration tools allow the Pharmaceutical LIMS to be adapted to your specific needs while ensuring that the validated core software remains untouched.
Raw Ingredients to Final Product Tracking
Whether testing finished goods with the creation of a final Certificate of Analysis (CofA), testing incoming raw materials, or testing intermediate product, Matrix Gemini Pharmaceutical LIMS helps you automate and control your sample testing and record data results to conform to regulatory requirements.
The solution drives quality throughout the pharmaceutical manufacturing flow by managing and tracking the samples taken and ensuring they can be quickly related to the relevant product and batch.
Stability Study Testing
Managing pharmaceutical stability testing can be very demanding, especially with small to medium size companies developing and producing over the counter, generic and new prescription 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.
Manually ensuring that approved protocols are followed precisely, including “pulls” being made on schedule with the appropriate tests being performed, can be both time consuming and tedious.
The laboratory must also ensure that any laboratory informatics system can interface with other enterprise system such as Enterprise Resource Planning systems (ERP) or Manufacturing Resource Planning Systems (MRP), etc. Enabling the laboratory to add value to the manufacturing process is key.
Matrix Gemini Pharmaceutical LIMS Overview
Supports many different kinds of QC samples and tests: Duplicates, Replicates, Spikes, Spike Duplicates, Controls, Control Duplicates. When grouping samples for analysis. Results from these QC tests can be used for calculating final results on samples, such as correcting for recovery and relative percent difference.
Matrix also includes capabilities for control and trend charts, with automatically calculated values for Standard Deviation and flags for data points which signal the need for further investigation into the quality of the results.
Matrix Gemini LIMS solution offers fast implementation without requiring programmers, ensuring an excellent fit to unique or specific user requirements and a system that can easily change with evolving future business needs.
The configurability of the Matrix Gemini Pharmaceutical LIMS means that it can be configured and re-configured to meet both current and future requirements without the need to write “one-off” custom code. The use of this standard but configurable solution means that the potential life of the system is extended and the cost of ownership reduced.
The pharmaceutical industry is not just about stability management , designed in conjunction with several major pharmaceutical companies, Autoscribe’s laboratory informatics product suite offers a solution to current and future needs of a laboratory. The products come with a suite of standard reports, together with detailed statistical analysis and graphics including shelf life projections, accelerated shelf life and more.
Matrix Gemini is uniquely feature genuine configuration capabilities, with no custom coding, ensure an exact fit to customer requirements for a wide range of laboratories and processes. Matrix Configuration Tools provide superior flexibility which results in fast implementation and an interface that is familiar and comfortable for each user. In addition, a product that is easy to configure results in a long system life and therefore a reduced cost of ownership.
