BioProcess International

Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in GxP Environments

Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in ...
BioProcess International

Cell- and Virus-Bank Characterization in Product Development: A Risk-Based, Phase-Appropriate Framework for Quality Control

Biopharmaceutical developers should introduce risk-based, phase-appropriate characterization strategies for quality control ...
BMJ Open

Implementation determinants of a planned machine learning-enabled surgical scheduling system in a high-volume orthopaedic centre in Canada: qualitative findin…

Objectives Elective non-emergent surgical wait times have increased across countries such as Canada, straining operating room ...
BMJ Global Health

Enhancing malaria-in-pregnancy monitoring: stakeholder experiences and data integration into the BornFyne-PNMS digital platform in Cameroon

Malaria in pregnancy (MiP) is a significant public health concern in high-burden malaria countries and a key predictor of ...