Compliance Posture

Written for sponsor, CRO, and biotech procurement teams evaluating AuditingLab for clinical quality assurance workflows.

Regulatory Framework Alignment

• ICH-GCP E6(R3): Aligned. Audit workflows, CAPA tracking, and document oversight are designed to support E6(R3) requirements.
• 21 CFR Part 11: Aware. Clerk-based user attribution, append-only activity trails, and validation packages available on request.
• GMP / GLP: Supported. Framework-specific audit prompting and report templates for GMP and GLP studies.
• HIPAA: Conscious. No PHI required to use the platform; BAAs available for Enterprise customers.
• GDPR / CCPA: Honored. Rights to access, export, and delete personal data are supported.

Compliance Roadmap

• SOC 2 Type II attestation (in progress)
• HIPAA BAAs for Enterprise customers
• ISO 27001 alignment
• Formal 21 CFR Part 11 validation package

For procurement questionnaires or compliance documentation requests, email support@auditinglab.com.