Case Study: xCures builds a compliant eQMS and saves hundreds of hours with Qualio

xCures saves hundreds of hours a year with Qualio

xCures, a health and wellness startup providing an AI platform for oncology treatment, faced significant compliance challenges. Their manual, paper-based quality management system was unable to meet the requirements of HIPAA, GDPR, and FDA regulations, which was highlighted by a critical sponsor audit. To gain control over their compliance program and prepare for an FDA 510(k) submission, they turned to the Qualio eQMS platform.

By implementing Qualio's cloud-based electronic quality management system, xCures centralized document management and integrated with tools like Jira. The solution provided by Qualio delivered substantial time savings, estimated to be hundreds of administrative hours per year—the equivalent of a full-time employee. This efficiency gain allowed the team to focus on their core competencies and confidently prepare for upcoming audits and regulatory submissions.

xCures