Regulatory Compliance
EvidAI is designed from the ground up for the most demanding regulatory environments. Our platform meets the stringent requirements of pharmaceutical, healthcare, and regulatory organizations worldwide.
Compliance Framework Overview
Systematic reviews submitted to regulatory bodies must meet rigorous documentation and traceability standards. EvidAI's architecture ensures your evidence synthesis work satisfies these requirements automatically.
| Regulation | Jurisdiction | Status | Description |
|---|---|---|---|
| 21 CFR Part 11 | FDA (USA) | ✅ Ready | Electronic records and signatures |
| GxP Guidelines | Global | ✅ Compliant | Good Practice standards |
| EU Annex 11 | EMA (Europe) | ✅ Compliant | Computerized systems validation |
| ICH E6(R2) | International | ✅ Aligned | Good Clinical Practice |
| PRISMA 2020 | International | ✅ Automated | Reporting standards |
| Cochrane Methods | International | ✅ Supported | Methodological standards |
21 CFR Part 11 Compliance
What 21 CFR Part 11 Requires
The FDA's 21 CFR Part 11 regulation establishes criteria for electronic records and electronic signatures. For pharmaceutical companies submitting evidence to the FDA, compliance is mandatory.
| Requirement | How EvidAI Addresses It |
|---|---|
| Audit Trails | Every action logged with timestamp, user, and IP address |
| Electronic Signatures | Cryptographically secure, legally binding signatures |
| Access Controls | Role-based permissions with principle of least privilege |
| Data Integrity | Immutable audit logs, checksums, version control |
| System Validation | IQ/OQ/PQ documentation available |
| User Authentication | Multi-factor authentication, session management |
Audit Trail Implementation
Every action in EvidAI generates an immutable audit record:
AUDIT LOG ENTRY
═══════════════════════════════════════════════════════════════
Timestamp: 2024-12-22 14:32:47.892 UTC
Event ID: EVT-2024122214324789-A7B3C9
User: dr.smith@pharma.com
User ID: USR-47829
Session: SES-9847362
IP Address: 203.45.167.89
Action: SCREENING_DECISION
Object: Study PMD-29847362
Object Type: Literature Record
DETAILS:
├── Decision: INCLUDE
├── Confidence: 94.2%
├── AI Models Consulted: 4 (GPT-4o, Claude-3.5, Gemini-1.5, EvidAI-Custom)
├── Model Agreement: 4/4 unanimous
├── Criteria Applied: Inclusion criteria v2.1
├── Previous Status: PENDING_REVIEW
├── Time to Decision: 3.2 seconds
ELECTRONIC SIGNATURE:
├── Signer: Dr. Sarah Smith
├── Meaning: "I have reviewed and approve this screening decision"
├── Timestamp: 2024-12-22 14:32:47.892 UTC
├── Signature Hash: sha256:a7b3c9d4e5f6...
└── Certificate: Valid through 2025-12-22
═══════════════════════════════════════════════════════════════
GxP Compliance
Good Practice Standards Supported
| Standard | Application | EvidAI Support |
|---|---|---|
| GCP | Clinical trials | Full audit trails, signature workflows |
| GLP | Laboratory studies | Data integrity, traceability |
| GDP | Data management | Version control, validation |
| GMP | Manufacturing | Documentation standards |
| GVP | Pharmacovigilance | Signal detection integration |
Computer System Validation (CSV)
EvidAI provides complete CSV documentation packages:
Validation Package: We provide IQ/OQ/PQ protocols and completed documentation for your validation files, reducing your validation effort by 80% compared to in-house tools.
Documentation Included:
- Installation Qualification (IQ) protocols
- Operational Qualification (OQ) test scripts
- Performance Qualification (PQ) acceptance criteria
- Validation summary reports
- Traceability matrices
- Risk assessments
PRISMA 2020 Automation
27-Item Checklist Tracking
EvidAI automatically tracks compliance with all 27 PRISMA 2020 checklist items:
| Section | Items | Auto-Tracking | Auto-Generation |
|---|---|---|---|
| Title | 1 | ✅ | ✅ |
| Abstract | 1 | ✅ | ✅ |
| Introduction | 2 | ✅ | ⚠️ Assisted |
| Methods | 12 | ✅ | ✅ |
| Results | 6 | ✅ | ✅ |
| Discussion | 4 | ✅ | ⚠️ Assisted |
| Other | 1 | ✅ | ✅ |
Real-Time Compliance Dashboard
Monitor PRISMA compliance throughout your review:
PRISMA 2020 COMPLIANCE: 25/27 Items (93%)
✅ COMPLETE (25 items)
├── Title identifies as systematic review
├── Structured abstract with all elements
├── Rationale described
├── Objectives stated with PICO
├── Protocol registration documented
├── Eligibility criteria specified
├── Information sources listed
├── Search strategy provided
├── Selection process described
├── Data collection explained
├── [... 15 more items ...]
⚠️ ATTENTION NEEDED (2 items)
├── Item 17: Study selection flow diagram
│ └── Status: Draft generated, awaiting approval
│ └── Action: [Review Draft] [Upload Custom]
│
└── Item 22: Certainty of evidence
└── Status: GRADE assessment incomplete for 2 outcomes
└── Action: [Complete GRADE] [Mark N/A]
[Generate Missing Items] [Download Checklist] [Export for Journal]
Data Security Architecture
Encryption Standards
| Data State | Encryption | Standard |
|---|---|---|
| In Transit | TLS 1.3 | NIST SP 800-52 |
| At Rest | AES-256 | FIPS 140-2 |
| Backups | AES-256 + separate keys | NIST SP 800-57 |
| Key Management | AWS KMS / HSM | FIPS 140-2 Level 3 |
Infrastructure Security
| Layer | Protection |
|---|---|
| Network | VPC isolation, WAF, DDoS protection |
| Application | OWASP Top 10 hardening, CSP headers |
| Database | Row-level security, encrypted connections |
| Access | Zero-trust architecture, MFA required |
Compliance Certifications
| Certification | Status | Scope |
|---|---|---|
| SOC 2 Type II | ✅ Certified | Security, Availability, Confidentiality |
| ISO 27001 | 🔄 In Progress | Information Security Management |
| HIPAA | ✅ BAA Available | Protected Health Information |
| GDPR | ✅ Compliant | EU Data Protection |
Enterprise Administration
User Lifecycle Management
| Feature | Capability |
|---|---|
| Provisioning | SCIM 2.0, JIT provisioning |
| Authentication | SAML 2.0, OIDC, MFA |
| Authorization | RBAC, ABAC, custom policies |
| Deprovisioning | Automatic on IdP removal |
Audit & Monitoring
COMPLIANCE DASHBOARD: Q4 2024
User Activity Summary:
├── Total Users: 847
├── Active This Month: 623
├── Reviews Conducted: 142
├── AI Decisions Made: 847,293
├── Human Overrides: 12,847 (1.5%)
Security Events:
├── Failed Logins: 234 (all blocked after 3 attempts)
├── MFA Challenges: 3,847 (100% success)
├── Suspicious Activity: 0 detected
├── Policy Violations: 0
Compliance Status:
├── 21 CFR Part 11: 100% compliant
├── PRISMA 2020: 97% avg completion
├── Audit Log Integrity: Verified
└── Backup Success: 100% (90-day retention)
Regulatory Submission Support
FDA Submission Packages
For New Drug Applications (NDAs) and Biologics License Applications (BLAs):
| Document | Format | Auto-Generated |
|---|---|---|
| Audit Trail Export | PDF, XML | ✅ |
| Methodology Report | Word, PDF | ✅ |
| PRISMA Checklist | Excel, PDF | ✅ |
| Forest Plots | High-res images, PDF | ✅ |
| Evidence Tables | Excel, Word | ✅ |
| Quality Assessment | Structured, PDF | ✅ |
EMA/NICE Submission Support
European regulatory bodies require specific formats:
- NICE STA template alignment
- EMA scientific advice documentation
- HTA body-specific exports
Best Practices
For Pharmaceutical Companies
- Validation First: Complete IQ/OQ/PQ before production use
- Role Separation: Distinct reviewer roles for dual review
- Change Control: Document all protocol amendments
- Periodic Review: Quarterly access reviews, annual validation
For Academic Institutions
- Research Ethics: Document IRB/ethics approvals
- Data Sharing: Configure appropriate access levels
- Publication: Use PRISMA exports for journal submission
Support Available: Our compliance team provides white-glove onboarding for regulated environments. Contact support@EvidAI.ai for validation support packages.