Aug 1, 2017
Precise Software Solutions Inc. (Precise) has been awarded a contract from the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) for Laboratory Information Management System (LIMS) implementation.
CBER is responsible for the safety, purity, potency, and effectiveness of biological products including vaccines, blood and blood products, and cells, tissues, and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions, or injury. The agency also works to defend the public against the threats of emerging infectious diseases and bioterrorism.
The contract will complete the implementation of CBER LIMS version 1.0. LIMS systems support laboratory operations by tracking specimens and workflows, aggregating data, and ensuring laboratory operations are compliant with various standards and regulations.
The project involves integrating, configuring, and harmonizing the STARLIMS commercial off-the-shelf (COTS) LIMS products for three CBER laboratories. The solution includes functions unique to CBER’s labs resulting in increased productivity, accuracy, and automated quality oversight of laboratory operations.
“We have been supporting LIMS efforts at the FDA for the Office of Regulatory Affairs (ORA) and are excited to expand our work, sharing our expertise with the CBER team,” said Dr. Zhensen Huang PhD, CEO of Precise. “Since contract award, our team has successfully adopted the agile approach to produce incremental features for our customer at the end of each sprint.”
The Contract was awarded for one year with five option years.