Life Science Services International (LSSI) founded in 1992 is supporting a global clientele in the pharmaceutical, medical device, and the biologics industries.

LSSI introduced LO1 Tracker in 2006 to provide an interactive system to track, trace, and control processes for in-process products from raw materials through to finished products. LO1 Tracker is an Automatic Identification and Data Capture (AIDC) and/or Radio Frequency Identification (RFID) based system designed to capture lot number, raw materials, processes, and other data in a manufacturing or process control environment. This information on work-in-progress and product quality is then fed to an ERP system such as JDE, SAP, etc. This system is designed to provide complete product process and material traceability for all products and provides capability for improved process and quality control.

In 2009 and 2010, LSSI designed LO1 Tracker enhancements for ebatch record processing, which will greatly simplify the pharmaceutical manufacturing data collection and quality control. These enhancements will provide real-time data collection and feedback on processing parameters and data points that are outside normal operating ranges or are showing undesirable trends. This will allow for improved response time for these events and more effective and timely corrective actions. The system will also facilitate reconciliation. We believe these will be valuable improvements for pharmaceutical and biologic companies, but will have applications in other industries too. LO1 Tracker is easily adaptable to any production environment. The system reduces and can eliminate the need for paper travelers and production work orders by completely automating the workflow. LO1 Tracker has been validated for life science environments meeting all FDA QSR, cGxP, 21 CFR Part 11, EMEA, MDD, ISO standards and other regulatory requirements including the Department of Defense standards.

In 2010 and 2011, LSSI handled the program management for a major quality system remediation project for a producer of in vitro diagnostics. This project, with over 90 people involved, was a complete update of the quality system based on the FDA QSIT approach.

In 2012, LSSI is managing a medical device software design and development project for a major infusion pump manufacturer. This project with personnel involved in five states is producing significant improvements over existing industry product capability.

LSSI has operating locations in Baltimore, Maryland; Chicago, Illinois; Dayton, Ohio; and Raleigh, NC; to better serve our clients. We will continue to expand our business and operating locations as needed to support our growing list of clientele.