Why Manual Screening Leads to Inconsistent Results
Manual literature and safety screening often appears reliable, yet it introduces hidden variability across teams and review cycles. When evaluation depends on individual interpretation, consistency becomes difficult to maintain.
This visual highlights four key drivers of inconsistent screening outcomes:
• Subjectivity in applying inclusion and relevance criteria • Reviewer fatigue in high-volume environments • Traceability gaps in documentation and audit trails • Shifting standards across teams or over time
For pharmacovigilance, medical affairs, and regulatory teams, inconsistent screening can slow signal validation, weaken compliance defensibility, and increase inspection risk. Structured workflows, standardized criteria, and transparent documentation are essential to ensure reproducible, audit-ready decisions.
Consistency in review processes strengthens regulatory confidence and improves long-term evidence governance.
