Stay compliant across every framework
QFacts Regulatory Compliance gives you a unified view of FDA, EMA, ISO, and industry-specific requirements, so you can assess gaps, implement controls, and stay audit-ready.
Built for multi-framework compliance
Whether you operate under FDA, EMA, ISO, or all of the above, QFacts keeps your compliance program organized and auditable.
Multi-framework compliance mapping
Map requirements from FDA 21 CFR Part 11, EMA Annex 11, ISO 13485, ISO 9001, and more, all in a single unified view.
Gap assessment and tracking
Identify compliance gaps against any regulatory framework, assign remediation actions, and track progress to closure.
Audit preparation tools
Generate audit-ready evidence packages, track findings, and maintain a history of all regulatory interactions.
Real-time compliance dashboards
Monitor compliance posture across all frameworks with live dashboards, trend indicators, and executive summaries.
Regulatory change alerts
Stay informed when regulations change. Get notified of updates that may affect your compliance posture and required actions.
Evidence-based control monitoring
Link controls to specific regulatory clauses, track evidence of compliance, and verify control effectiveness on schedule.
Compliance lifecycle
A continuous process from requirement mapping to executive reporting.
Map Requirements
Import or define regulatory requirements from applicable frameworks and map them to your processes.
Assess Gaps
Evaluate current compliance status against each requirement and identify areas needing remediation.
Implement Controls
Define and deploy controls to address gaps, assign owners, and set implementation timelines.
Monitor
Continuously monitor control effectiveness with scheduled reviews, automated checks, and real-time alerts.
Report
Generate compliance reports, audit evidence packages, and executive dashboards on demand.
Real-world use cases
See how compliance professionals use QFacts every day.
See how Compliance Officer uses Regulatory Compliance to map FDA 21 CFR Part 11 requirements to internal processes, identify gaps, and generate remediation plans.
See how Quality Director uses Regulatory Compliance to prepare for an EMA inspection by reviewing compliance status, gathering evidence packages, and tracking open findings.