S1E64 - Traceability Requirements and Documentation Audit Trails with Dr. Basant Bajpai, CEO of Compliance MedQRA

Quality management system implementation delays create cascading failures across medical device development timelines. Startups using SharePoint or Google Drive for documentation discover at audit time that these tools provide no traceability, no version control, and no evidence of systematic processes.

Dr. Basant Bajpai discusses why design controls begin at the concept stage, regardless of whether companies acknowledge them, how reverse documentation costs 6-12 months when manufacturers reach the submission stage without proper systems, and what happens when scaling exposes foundational quality gaps.

Simple automated systems that enforce traceability outperform both manual approaches and enterprise platforms...