Stability testing is a critical process for monitoring product quality under various conditions over time. Manufacturing FDA-regulated products necessitates thorough testing to ensure compliance with pharmacopeial specifications before release. External factors, such as light, temperature, and humidity, can impact product quality, making stability study management essential for maintaining product safety and efficacy.
Matrix Gemini LIMS Stability Management offers a cutting-edge digital solution for managing stability studies and minimizing errors associated with manual, paper-based processes. Matrix Gemini LIMS Stability Management integrates quality control, compliance, and electronic lab notebook (ELN) features, providing a comprehensive solution for meeting global regulatory guidelines.
Matrix Gemini LIMS handles all types of statistical models ensuring an accurate shelf-life evaluation, including:
Define product, batch, and storage conditions
Specify desired storage conditions and time intervals
Set start times for each storage condition
Label and store samples systematically
Record results on Lab Work Order (LWR) forms
Initiate, verify, and approve study results
Schedule and request sample pulls
Review the final approved LWR
Analyze data and compile comprehensive stability reports
Stability study software benefits your stability laboratory in several ways, including:
Stability study management software can enable easier collaboration between different teams or departments, allowing for better communication and more streamlined processes.
Stability study management software can automate many processes, reducing the need for manual intervention and freeing up staff time for more valuable tasks.
Stability study management software can help ensure compliance with regulatory requirements, such as FDA guidelines, by providing audit trails and record keeping.
With better access to data and insights, stability study management software can help laboratory staff make more informed decisions about product stability, shelf life, and formulation changes.
With Matrix Gemini LIMS Stability Management, you can operate more efficiently, reduce errors and waste, and improve the quality and accuracy of your data and processes.