Articles tagged with “change-control”

FDA Digitally Derived Measures in Clinical Trials

A 2026 evidence matrix for FDA digitally derived measures, covering endpoint roles, verification, validation, missingness, change control, and a stride-length example.

24 min read

9/19/2026

fda digitally derived measures digital endpoints clinical trials digital biomarkers sensor-based endpoints analytical validation clinical validation digital health technologies change control

Pharma Quality Agreements: What to Include (Sponsor vs CDMO)

Learn what must be included in a pharma quality agreement. This 2026-updated guide covers key clauses, sponsor vs. CDMO responsibilities, and GMP regulatory requirements including FDA 2016 guidance, EU GMP Annex 1 (2023), ICH Q9(R1), and DSCSA.

60 min read

1/8/2026

quality agreement cdmo gmp pharmaceutical manufacturing fda guidance sponsor vs cdmo change control quality management system contract manufacturing

Deviations, CAPA, and Change Control: A Workflow Guide

Learn the integrated workflow for manufacturing deviations, CAPA, and change control in GMP. This guide covers regulatory requirements and common inspection pit

40 min read

1/6/2026

capa change control manufacturing deviation quality management system gmp root cause analysis regulatory compliance iso 13485