Matrix Gemini LIMS Pharmaceutical Product Development

The Matrix Gemini LIMS Pharmaceutical Product Development platform is designed to streamline and expedite the development processes of drugs, devices, and therapeutic formulations. It offers scientists and product development teams the tools to create tailored protocols and study designs, enhancing the efficiency of biopharmaceutical and generic drug development.

This comprehensive system features substance management capabilities, allowing the detailed tracking of laboratory materials. Users can effectively record the receipt, movement, and use of materials, with labels and inventory reports being generated instantly after new materials or containers are registered.

Key Functionalities

• Design and customize workflows to align with formulation processes.
• Maintain comprehensive materials master records, along with archival and disposal records.
• User-defined template formulation instructions tailored to site-specific SOPs.
• Inventory management, tracking, and monitoring of materials via a flexible interface.
• Compliance with 21 CFR Part 11 electronic signatures and audit trail requirements.
• Automated integration for online execution of formulations, supporting supervisory reviews and approvals.
• Utilization of barcode labeling and scanner interfaces, as well as bi-directional interfaces for balances.

Users can perform target list calculations such as direct additions, stock dilutions, and serial dilutions with ease. The associated modules detail the necessary actions, offering step-by-step guided instructions for seamless workflow implementation.

The platform supports regulatory compliance and efficiency by replacing stand-alone applications and paper records with a unified digital solution. Organizations can achieve up to 30% cost reductions while ensuring compliance, quality, and data integrity are embedded in every aspect of their operations.

Further enhancing its utility, the module supervises materials' receipt, supplier registration, and tracking across laboratory areas, facilitating an in-depth overview of drug substances, vehicles, and excipients movements. It allows for easy preparation of hazard statements and safe handling instructions through its 'master paragraph' function.

Matrix Gemini LIMS presents a tailored solution addressing specific business needs, promoting workflow efficiency and regulatory compliance while supporting a wide variety of formulation types through user-friendly and highly customizable interfaces.