02.27.25 -- A New Approach For Minimizing Human Errors In Biopharmaceuticals

The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.

Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.

Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.