Recommended start
Sentinel secondary inspection
A pragmatic approach to adding secondary inspection oversight on legacy lines: surfacing ambiguous cases, supporting QA decision-making, and improving narrative defensibility.
Fulcrym technical briefs
White papers
Six focused papers for QA, engineering, and operations teams running solid oral dose lines. Each is designed to be skimmable, defensible, and grounded in real inspection realities.
Risk & cost
Reducing recall risk
How escapes translate into operational disruption: remediation, investigations, downstream customer impact, and why legacy inspection gaps remain hard to close without added oversight.
Validation-safe
No revalidation approach
A framing for adding oversight alongside validated processes: how to evaluate secondary inspection without triggering disruptive revalidation, downtime, or line redesign.
Cost of quality
CoPQ for solid dosage manufacturing
A practical breakdown of the cost of poor quality in US solid oral dose: scrap, rework, deviations, complaints, and recall-driven disruption.
Regulatory shifts
FDA harmonization for domestic CDMOs
What FDA harmonization means for domestic solid dosage manufacturers: inspection volatility, expectations alignment, and how secondary inspection can de-risk compliance cycles.
Deviation trends
Trends in GMP deviations (2004–2024)
A 20-year analysis of domestic U.S. solid oral dose deviations, with a focused look at recent performance, regulatory signal, and operational impact for modern CDMOs.