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Best Regards, The Allyfe Team.
Best Regards, The Allyfe Team.
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Deep compliance audit of your TMF. Identify ALCOA+ gaps, document violations, and quantify inspection risks.
Prioritized action plan to close compliance gaps. Clear ownership, timelines, and success criteria.
Ongoing compliance tracking, deviation alerts, and real-time inspection readiness dashboard to catch issues before regulators do
Allyfe's Inspection Readiness Assessment is a comprehensive compliance audit of your clinical trial documentation. We conduct a deep analysis of your Trial Master File to identify ALCOA+ violations, missing critical documents, and regulatory risk areas.
Our assessment delivers:
- Complete TMF compliance mapping against FDA/EMA expectations
- ALCOA+ violation identification (Attributability, Legibility, Contemporaneity, Originality, Accuracy + Completeness, Consistency, Enduring, Available)
- Severity classification of each deviation
- Prioritized remediation roadmap with clear ownership and timelines
- Risk quantification showing likelihood and impact of regulatory findings
Unlike generic compliance reviews, our assessment is tailored to your specific trial type, study phase, and regulatory pathway. We work with your teams to ensure findings are actionable and realistic to fix.
Once compliance gaps are identified, the path forward matters. Our Remediation Roadmap translates assessment findings into an executable plan.
We help you:
- Prioritize fixes by regulatory impact and implementation complexity
- Define clear ownership — who fixes what, by when
- Design remediation workflows to prevent future violations
- Build sustainable processes so compliance issues don't resurface
- Create evidence trails that demonstrate proactive compliance to regulators
Whether you need to rebuild TMF structure, implement new quality control workflows, or close specific document gaps, we guide your team through execution. Our goal is simple: inspection-ready documentation, delivered on your timeline.
Compliance risk doesn't end after remediation. Our Continuous Monitoring service ensures your TMF stays inspection-ready throughout the trial lifecycle.
With real-time visibility into:
- Document completeness — missing required documents flagged immediately
- ALCOA+ compliance — automated checks for attributability, legibility, and protocol adherence
- Deviation tracking — anomalies caught early, not at inspection
- Inspection readiness scoring — live dashboard showing your compliance status
This transforms inspection readiness from a one-time event into an ongoing operational standard. Your teams get proactive alerts, your regulators see compliance excellence, and your inspection risk stays low throughout the trial.
