Legend Biotech is a global clinical-stage biopharmaceutical company focused on the discovery and development of novel cell therapies. Founded in 2014, the company quickly outgrew its manual, disconnected approach to document management. Paper-based processes didn’t scale. Collaboration via email was inefficient. And multiple document repositories created redundant workflows and inconsistent document formats across the organization.
Harmonizes Global Document Management Across GxPs
Legend Biotech aimed to replace legacy systems and processes with modern technologies and industry best practices to mitigate compliance risks and achieve cross-functional collaboration.
The company implemented Vault QualityDocs as its global source of truth across GLP, GCP, GMP, and GVP documents to meet the rapid turnaround time required to manufacture cell therapies. The rollout was completed in just nine weeks, leveraging as much pre-validated, out-of-the-box functionality as possible.
Fewer Redundancies, More Collaboration with Centralized Document Management
A centralized document management approach improved collaboration globally and made quality processes more efficient. A single source of truth reduced duplicate document records and streamlined access, print, and scanning of documents for all the user groups. Automated periodic reviews improved compliance, and standardized templates ensured consistent look and feel of documents across the U.S., Chinese, and European sites.
Looking ahead, Legend Biotech envisions many more ways to improve efficiency, consistency, and collaboration with Veeva QualityDocs. The company plans to give external partners access to the system, which will facilitate the flow of information and work across its manufacturing network. New electronic forms will streamline data capture and additional document templates will drive standardization as the company’s global growth continues.