RBQM Updates for Clinical Experts

Mar 2022

Release Notes | MyRBQM® Portal Version 6.8.2

By |2022-03-17T06:54:54+02:00March 17, 2022|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 6.8.2

MyRBQM Portal V6.8.2 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

Jan 2022

Release Notes | MyRBQM® Portal Version 6.8.1

By |2022-01-26T18:21:38+02:00January 26, 2022|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 6.8.1

MyRBQM Portal V6.8.1 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

Nov 2021

Release Notes | MyRBQM® Portal Version 6.8.0

By |2021-11-19T15:40:10+02:00November 19, 2021|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 6.8.0

MyRBQM Portal V6.8.0 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

Oct 2021

Milestone | We Have Just Received our ISO 9001:2015 Certificate

By |2024-10-17T15:25:55+02:00October 26, 2021|Blog, News|Comments Off on 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.

Oct 2021

Quality by Design | ICH E8(R1) General Considerations for Clinical Studies

By |2024-11-25T17:39:19+02:00October 17, 2021|Blog, Free Infographics, Good Clinical Practice|Comments Off on 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.

Sep 2021

Risks of IMP Management Under Standard vs. Pandemic Conditions

By |2024-11-25T19:59:49+02:00September 30, 2021|Blog, Case Studies|Comments Off on 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.

Sep 2021

Release Notes | MyRBQM® Portal Version 6.7

By |2021-12-22T17:23:16+02:00September 22, 2021|News, RBQM Product Updates|Comments Off on 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.

Aug 2021

Release Notes | MyRBQM® Portal Version 6.3.3

By |2021-12-22T17:22:33+02:00August 2, 2021|News, RBQM Product Updates|Comments Off on Release Notes | MyRBQM® Portal Version 6.3.3

MyRBQM Portal V6.3.3 released! We're constantly working to improve your Risk-Based Quality Management experience. Download the summary of what has changed.

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