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One platform for all your regulatory quality management needs
Ask questions about regulations and get cited answers instantly from our AI trained on federal regulations.
Generate SOPs, policies, and procedures from templates with AI assistance. Stop wrestling with Word docs.
Automated gap analysis against 21 CFR 1271 and 42 CFR 493 regulatory requirements.
AI auto-fills forms using your organization data and regulatory requirements. Save hours on paperwork.
Secure document management with privacy controls, version tracking, and 21 CFR Part 11 compliance.
Complete, tamper-evident audit logging that satisfies regulatory inspection requirements.
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Select HCT/P for cell therapy or CLIA for clinical laboratories
Create your organization profile and invite team members
Ask compliance questions and generate documents with AI assistance
Run compliance checks and maintain electronic records with full audit trails
Security and compliance are not afterthoughts
Enterprise-grade security infrastructure
Data encrypted at rest and in transit
Compliant audit trails and e-signatures
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