From eTMF Completeness to eTMF Quality Excellence
The Completeness Mindset: Where It All Began For years, the primary benchmark for a healthy Trial Master File was straightforward: Is everything there? Regulators asked for it. Inspectors measured it. Quality teams chased it. The DIA Reference Model and ICH E6 (R2) gave sponsors a checklist, and completeness scores became the headline metric. In Veeva…