Laboratory Information Management System Has Been Validated and is Part 11 Compliant
APRIL 19, 2016—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has officially launched a new laboratory information management system (LIMS), Watson LIMS™, at its advanced lab facilities in North Carolina’s Research Triangle area. The system enables BioAgilytix to further improve its data capture and management capabilities for a wide range of large molecule assays and methods, with the majority of their workflows now able to be run through the LIMS software in a standardized fashion. “Watson LIMS™ is a powerful tool for our team because of its ability to efficiently handle a variety of workflows, large volumes of study data, and more readily translate those data into the formats needed for review and reporting,” said Jim Datin, Chief Executive Officer of BioAgilytix. “With this system, we’re now better equipped than ever to handle large clinical studies.”
BioAgilytix conducted a validation of the Watson LIMS™ software prior to implementation, to ensure the system is in compliance with Part 11 requirements and performs optimally within the context of their operating workflows. “It was very important to us to take the time to carefully validate the software before it was officially introduced across our lab’s operations,” said Datin. “We want customers to have the utmost confidence that our workflows will only be enhanced with this tool, and that we will continue to uphold the rigor of quality and regulatory compliance that their projects demand. The validation proves that we can do all of this, and now in even more streamlined ways.”
Dr. Steven Michael, Senior Vice President of Operations at BioAgilytix, commented that “We’re committed to investing in strategic technologies to continually advance our state-of-the-art lab and keep us at the forefront of innovation. Watson LIMS™ leads the industry in bioanalytical laboratory information management, and now we can offer its breadth of benefits—including flexibility, efficiency, high throughput, and automated standardization—to our customers in support of their large global studies.”
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. Located in North Carolina’s Research Triangle area, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, GLP, GCP, and GCLP, as well as product release testing under GMP.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to 22 of the top 25 global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.