Quality Management Software Consolidates Multiple Quality Systems into Single, Part 11 Compliant Electronic Repository
OCTOBER 7, 2016—Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has launched a new quality management software system, Quality Collaboration by Design (QCBD™), at its advanced laboratory facilities to further streamline management of key Quality Management Systems (QMS). This system consolidates multiple systems that were formerly paper-based into a single electronic repository, with modules for managing documents and change controls, deviations, investigations, corrective and preventative actions, and sponsor complaints, as well as for equipment management, vendor management, and training management. In addition to being an environmentally friendly solution for the long-term management and storage of quality documentation, the QCBD implementation will also help BioAgilytix drive new levels of efficiency by reducing turnaround times for QMS documents and records that must be reviewed by multiple people for approval. Now QMS documents and records can be routed electronically, and each BioAgilytix team member can gain a single dashboard view with alerts of the action items they must address at any given time.
“QCBD is helping us to further streamline and fortify a number of day-to-day processes so that we can provide the quick turnarounds that our customers expect while still maintaining quality outputs,” said Christine Lakins, Corporate Compliance Manager at BioAgilytix. “Through the software, we can have alerts auto-triggered for everything from equipment calibrations due to SOP or site change updates, and employees can electronically track their training progress to keep up to date with required training needs. These automation capabilities will both strengthen productivity and ensure we are continuously meeting our quality management objectives.”
BioAgilytix conducted a validation of the QCBD software prior to implementation to ensure its compliance with 21 CFR Part 11, Annex 11, and Annex 15 requirements, which call for a high standard of integrity and security for electronic records and electronic signatures. “It was a priority for us to validate the system before implementing it officially across the organization, to assure our customers that our quality records will remain secure and confidential,” said Lakins. “We’re committed to investing in systems that will continue to enhance our quality processes for the benefit of BioAgilytix employees and our customers, and QCBD will help us to be more efficient so that we can focus on innovation and responding quickly to our customers’ needs.”
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, 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 23 of the top 25 global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.