Case Study: Welldoc achieves zero findings in audit reports with Ostendio

How Ostendio Helps Welldoc Keep Up with Scale, Achieve Rare Zero Findings in Regulatory Audit

Welldoc, a digital health company that supports chronic care management, needed a better way to handle document management, training, and regulatory compliance as it grew rapidly and expanded its product line. Its older electronic document management system was costly, cumbersome, and didn’t scale well, making it harder to keep up with FDA, ISO, MDSAP, HITRUST, and SOC 2 requirements. Ostendio’s FDA-compliant documentation and training platform was chosen to centralize these compliance processes.

With Ostendio, Welldoc improved document control, evidence collection, retrieval, and employee training tracking through centralized Documentation and Training modules. The team used the platform in real time during audits and was able to quickly provide complete version histories and required records, helping them earn zero findings in a recent MDSAP recertification audit. Welldoc also doubled its workforce from 100 to 200 employees while maintaining compliance, and auditors regularly praised its well-controlled quality management system.

WellDoc

Larry Ludensky

Quality Systems Management and Implementation