Articles tagged with “regulatory-guidelines”

Open Source GxP Compliance: Avoiding Vendor Lock-In

Examine evidence for open-source software in GxP environments. Learn how validation strategies enable compliance while eliminating proprietary vendor lock-in.

35 min read

2/9/2026

gxp compliance open source software vendor lock-in software validation 21 cfr part 11 regulatory guidelines pharmaceutical it data integrity

Patient-Reported Outcomes (PRO) Systems: A Clinical Trial Guide

Learn about Patient-Reported Outcomes (PRO) systems in clinical trials. This guide covers ePRO data collection, PROMs, FDA PFDD guidelines, CONSORT 2025 updates, AI-driven ePRO platforms, and challenges

35 min read

10/14/2025

patient-reported outcomes epro clinical trials proms regulatory guidelines byod clinical data collection