Trust & Compliance

Security at XELLabs

Built for regulated laboratories - security and compliance are architectural foundations, not add-ons.

HIPAA21 CFR Part 11ISO 17025CLIAGxPSOC 2 (Azure)
0/100SECURITY SCORE
Platform Security
Industry-leading protection
Continuously monitored & tested
Threats Blocked Today
-
Updated in real-time
HIPAASOC 2ISO 27001GDPR ReadyPCI DSSFedRAMP Ready

Compliance Certifications

🏥
HIPAA
Certified
2024â–¼

Full HIPAA compliance covering Administrative, Physical, and Technical Safeguards. Annual third-party assessments conducted by certified HIPAA auditors. BAA available for all customers.

📋
21 CFR Part 11
Compliant
2024â–¼

Complete electronic records and electronic signature (ERES) implementation satisfying all FDA 21 CFR Part 11 requirements. IQ/OQ/PQ validation documentation available.

🔬
ISO 17025
Accredited
2023â–¼

LIMS architecture designed to support ISO/IEC 17025:2017 quality management requirements. Implementation guide and pre-configured QMS templates included.

🧬
CLIA
Ready
2024â–¼

CLIA-ready workflows for personnel management, proficiency testing tracking, and quality control documentation required for clinical laboratory certification.

⚕️
CAP
Supported
2024â–¼

Built-in CAP checklist tracking, document control, and inspection readiness tools to maintain College of American Pathologists accreditation.

💊
GxP
Validated
2024â–¼

GxP-compliant validation lifecycle support including URS, FS, DS, IQ, OQ, PQ documentation frameworks and change control workflows.

Security Controls

🔐Encryption
  • ✓AES-256 encryption at rest for all data
  • ✓TLS 1.3 in transit - no downgrade allowed
  • ✓Field-level encryption for PHI/PII
  • ✓HSM-backed key management
  • ✓Automatic key rotation every 90 days
Have a security question?
Our security team responds within one business day.
Contact Security Team