Industry News

KEYWORDS FDA / Industry News

Eksigent Taps Agile for PLM Solution

Agile Software announced that Eksigent Technologies, a pioneer in microfluidic systems that automate and accelerate a number of life science applications, has deployed Agile Advantage 2005 as its corporate product lifecycle management (PLM) solution. Anticipating a need for a state-of-the-art PLM system as it transitions from a primary focus on research to the development and delivery of innovative products, Eksigent chose Agile Advantage 2005 to meet the company’s current and future needs.

“We have been concentrating on research and proof-of-concept demonstrations for the past three years, but now we are becoming a full-fledged manufacturer of medical devices, requiring us to meet FDA and ISO requirements for quality and regulatory reporting,” says Richard Rush, head of medical device business development activity at Eksigent. “We have determined that the right PLM solution implemented ahead of the process is critical as we build up our quality systems.”

“By using Agile Advantage to manage product record information and FDA Title 21 CFR Part 11 requirements, Eksigent is optimizing the quality management, regulatory compliance, and product realization processes of its early-stage research investments,” said Joe Hage, general manager of Agile Small Business Solutions.

DataLabs Unveils Data Management Tool

DataLabs, a developer of web-based software applications for clinical development, announced availability of DataLabs Clinical, a single data management system that unifies the functionality of paper data entry with the flexibility of electronic data capture, the company said.

DataLabs Clinical is an electronic clinical data management platform that enables the biopharmaceutical and contract research organizations industries to streamline clinical data management processes and reduce the time and costs associated with clinical trials.