Milestone | We Have Just Received our ISO 9001:2015 Certificate
Today we are proud to announce another milestone for our organization. Being ISO certified means that our QMS drives the three key principles of ISO 9001.
Quality by Design | ICH E8(R1) General Considerations for Clinical Studies
The final version of the ICH E8(R1) guidance discourages the old-school "one size fits all" approach. Instead, risk-based quality management concepts such as QbD and CtQ factors predominate these modern-day considerations which encourage the biopharma industry to go beyond the traditional checklists. We've visualized the final 2021 guidance, "General Considerations for Clinical Studies," for you.
Risks of IMP Management Under Standard vs. Pandemic Conditions
The COVID-19 pandemic has accelerated alternative distribution strategy adoption to facilitate “new normal” decentralized and hybrid trial concepts. Capturing the IMP supply chain risks associated with these more flexible distribution approaches requires synergy among people, processes, and technology. Former Senior Project Manager at GKM, Anke Mueller, shares with you how pandemic-induced supply chain risk data knitted together in a single RAC tool enabled her study team to pivot quickly and continue their studies in a timely fashion.
Release Notes | MyRBQM® Portal Version 6.7
MyRBQM Portal V6.7 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.