Pharmaceutical LIMS & Stability Study Management

Managing drug development and testing in pharmaceutical laboratories has never been so easy.

The global pharmaceuticals market is worth over $750 billion a year, a figure that is expected to continue to rise. In a highly competitive and increasingly expensive market place it is important that cost efficiencies are maximized, while meeting all critical compliance requirements.

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.

LIMS in Pharmaceutical Stability 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 pharmaceutical 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.

Key Features of the Matrix Gemini Pharmaceutical LIMS:

  • Sample, lot and batch management (from registration to disposal)
  • Workflow, work allocation and scheduling management
  • Traceability for regulatory compliance with GAMP, GLP, 21 CFR Part 11, etc.
  • Lab instrument integration to automate data collection
  • Alerts based on test thresholds, user authorization, etc.
  • Tiered security with built-in chain of custody
  • Interfaces with enterprise (ERP, MRP) systems
  • Graphical configuration tools
  • Many pre-configured pharmaceutical LIMS options

The Complete Laboratory Solution

Today, laboratories must be able to adapt their processes and workflows, and their LIMS and tracking solution must stay in step with these changes. Autoscribe Informatics' 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.

Our solutions include:

Case Study 1

Thornton & Ross introduced Matrix Gemini LIMS for Pharmaceutical QC.

Case Study 2

Catalent introduced Matrix Tracker to improve drug development tracking in their laboratory.

Next Steps

Please contact us for more details or for a web demonstration.