Compliance & Regulatory
21 CFR Part 11 · ICH-GCP · HIPAA · GDPR
96%
Overall Compliance Score
142 controls met
6 partial
0 critical gaps
21 CFR Part 11
Electronic records and signatures
ICH-GCP
Good clinical practice
HIPAA
Health information privacy
GDPR
Data protection regulation
Control Categories
Authentication & Access100%
Audit Trail Integrity100%
Electronic Signatures98%
Data Encryption100%
Change Control95%
Backup & Recovery92%
Recent Audits
Internal AuditPass
9/15/2024 · 2 findings
FDA InspectionPass
8/1/2024 · 0 findings
GDPR AssessmentPass
6/20/2024 · 4 findings
SOC 2 ReviewPass
5/10/2024 · 1 findings
Platform Compliance Features
Immutable Audit Trails
Cryptographic hash chaining for tamper-evident logs
Field-Level Encryption
AES-256-GCM with KMS envelope for PHI protection
Digital Signatures
SHA-256 signing with metadata binding per 21 CFR Part 11
Version Control
Complete change history with user accountability
Pending Action Items
Complete Q3 validation documentation
Due in 5 daysmedium
Review password policy updates
Due in 12 dayslow
Annual privacy training renewal
Due in 18 daysmedium