YearlingIQ for Healthcare & Life Sciences
FDA-aligned QMS. AI-powered compliance. Continuous audit readiness.
HIPAA Compliance
Audit & Framework Management
Audit Ready Score
164 requirements monitored
FDA documentation review
8
Frameworks
12
Audits Passed
Healthcare compliance requires continuous attention across multiple frameworks. YearlingIQ goes beyond compliance tracking: it embeds a full FDA-aligned Quality Management System (QMS) for 21 CFR Part 11 and Part 820, quantifies risk in financial terms using dollar-denominated loss modeling, and surfaces third-party vendor risk through built-in TPRM with OSINT enrichment, so your teams can focus on patient care and operational excellence.
When a regulator or auditor asks a complex question, AskIQ, YearlingIQ's AI compliance assistant, can draft a framework-grounded response in seconds, referencing your actual control evidence. No more blank-page narrative writing under deadline.
The platform covers HIPAA, HITECH, FDA 21 CFR Parts 11 and 820, HITRUST, GxP, ISO 27001, and GDPR for health data, maintaining continuous compliance readiness across your healthcare operations.
Platform Differentiators
AskIQ
AI compliance assistant that drafts HIPAA attestation narratives, FDA audit responses, and corrective action plans grounded in your actual control evidence.
FDA-Aligned QMS
Built-in quality management system aligned to 21 CFR Part 11 (electronic records) and Part 820 (quality system regulation) for medical device and pharmaceutical operations.
TPRM with OSINT Enrichment
Assess vendor risk across EHR vendors, medical device suppliers, and lab partners. OSINT enrichment surfaces breach history and public risk signals automatically.
Quantitative Risk Modeling
Translate compliance gaps into dollar-denominated risk exposure using Monte Carlo loss modeling, giving executives and boards a financial view of healthcare risk.
Regulatory Framework Management
- HIPAA compliance tracking with comprehensive control mapping
- FDA-aligned QMS covering 21 CFR Part 11 (electronic records) and Part 820 (quality system regulation)
- HITRUST, GCP, and GxP framework alignment for clinical operations
- ISO 27001 and GDPR for health data privacy and protection
- Quantitative risk scoring to translate compliance gaps into dollar-denominated exposure
- AskIQ AI assistant drafts HIPAA attestation narratives and FDA audit responses from your evidence
Clinical and Research Compliance
- Compliance tracking mapped to healthcare operational workflows
- Clinical trial compliance with GCP requirement monitoring
- Adverse event reporting integrated with pharmacovigilance workflows
- FDA-aligned QMS with document control, CAPA workflows, and deviation tracking
- Research data integrity monitoring for clinical documentation
- Regulatory submission preparation with automated evidence collection
Healthcare Operations Support
- Executive dashboards with compliance metrics and audit readiness indicators
- Built-in TPRM with OSINT enrichment for EHR vendors, medical device suppliers, and lab partners
- Healthcare-specific threat intelligence and security monitoring
- Integrations with Epic, Cerner, and common healthcare information systems
- Comprehensive audit trails for regulatory inspections
- Trust Center publishing real-time compliance posture to partners and regulators
Built for Healthcare Trust
Perfect For
Organizations facing real compliance challenges in healthcare and life sciences
Hospitals transitioning from spreadsheet-based HIPAA compliance to centralized tracking systems
Life sciences organizations preparing for FDA inspections with comprehensive audit readiness
Clinical research operations managing GCP requirements across multiple studies
Pharmaceutical companies centralizing pharmacovigilance and quality management workflows
Healthcare IT teams integrating compliance across Epic, Cerner, and multiple information systems
Compliance officers managing visibility and control across multiple healthcare locations
Organizations preparing FDA inspection documentation with automated evidence collection
Multi-site healthcare systems standardizing compliance programs across all facilities
Proof in Regulated Industries
How YearlingIQ holds up in environments where audits and evidence really count.
See YearlingIQ in your hospital or health system
Book a walkthrough tailored to healthcare and life sciences compliance, from HIPAA and HITRUST to FDA 21 CFR and TPRM.