FDA brings new workflow software into its labs

In the past, the FDA has been criticized for its "antiquated" IT systems--in 2007, the FDA's Subcommittee on Science and Technology described the FDA IT infrastructure as obsolete, unstable, and lacking sufficient controls to ensure continuity of operations or to provide effective disaster recovery services. The organization has been planning an IT overhaul since 2009; another step to bring its technology into the 21st century comes through a new agreement with Abbott Laboratories ($ABT).

The FDA is licensing the company's STARLIMS technology, a laboratory information management system (LIMS) that is designed to improve the reliability of processes in laboratories, support compliance with regulations and industry standards, and provide reporting, monitoring and analysis capabilities.

STARLIMS will be installed in the FDA's Office of Regulatory Affairs (ORA) laboratories, where government scientists test food and drug chemistries, devices, forensics material and microbiology samples. The laboratories generate huge amounts of information, and using LIMS will help more than 800 users manage the work flow by providing support for sample accountability, data analysis, document control, report generation, and other lab operation functions.

"We're looking forward to working on this important initiative," said Isaac Friedman, head of Abbott's STARLIMS business. "STARLIMS has a successful track record in implementing web-based LIMS for life sciences organizations, public health laboratories and a number of federal agencies."

- read the press release

Suggested Articles

There's no evidence personal patient information leaked during the 11-week breach, but the same can't be said about Sangamo's own secrets.

Through a new online tracker, AllTrials names sponsors who fail to report clinical trial results on time per the FDAAA Final Rule.

The new solution aims to streamline the incorporation of human genomic data into clinical trial designs.