Quality Systems

Steps Towards Demystifying Risk-Based Decision Making

It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.

Computer Validation Confirms Evidence

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.

Digitalization of QbD Risk Assessments

Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.

Bridging Gaps and Investing in Change

January 03, 2024

European bio/pharma companies have no choice but to invest and adapt to the evolving industry needs.

Developing an Optimized Risk Assessment Portfolio—The Quality Risk Management Master Plan

January 03, 2024

A thoughtfully constructed QRM Master Plan translates the strategy and enables a risk-based approach.

Bringing Collaboration to the Horizon Once More

January 03, 2024

UK scientists are once again able to participate in the Horizon European research programme thanks to a deal struck in 2023.

Proving It’s Clean with Analytics

January 02, 2024

Analytical methods and tools play a pivotal role in cleaning validation.

Finalizing the European Health Data Space

January 02, 2024

The EHDS aims to increase access to health data, but how will it impact pharma?

Are You Ready for Inspection?

January 02, 2024

Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.

The Decline and Fall of the Clinician–Scientist

December 29, 2023

Clinician-Scientists are vital innovation spark plugs, accounting for 40% of Nobel awards in Physiology or Medicine, and two thirds of Big Pharma CSOs.

European Medicines Regulatory Network on Track to Meet Goals

December 27, 2023

The midterm report of the European Medicines Agencies Network Strategy finds that the network has strengthened and is on track to achieve its objectives.

A Record Year for Disease Elimination

December 26, 2023

WHO provides a look at the world’s health as the agency turns 75.

FDA Publishes Guidance on Real-Word Data

December 21, 2023

The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.