Compliance Documentation
BrainPredict OÜ maintains comprehensive compliance with global data protection, security, and healthcare regulations. All documentation is available for audit purposes.
🏆 Compliance Status Overview
Certification Roadmap
SOC 2 Type II Audit
Investment: €20K
Benefit: Enterprise requirement
ISO 27001 Certification Audit
Investment: €25K
Benefit: International credibility
Annual HIPAA Risk Assessment
Investment: €5K
Benefit: Maintain compliance
Contract Template Guidelines
| Contract Type | Key Terms to Include | Risk Mitigation |
|---|---|---|
| SaaS Agreement | Clear SLA, liability caps, IP ownership | Limit liability to fees paid |
| Enterprise Agreement | Custom terms, security addendum | Higher liability for larger deals |
| Partner Agreement | Revenue share, territory, exclusivity | Clear termination clauses |
| NDA | Mutual, 2-year term, standard carve-outs | Avoid perpetual terms |
| DPA (GDPR) | Sub-processors, data location, rights | Standard contractual clauses |
📄 Compliance Documents
SOC 2 Control Matrix
47 controls across Common Criteria, Availability, and Confidentiality - 95% effective
ISO 27001 Statement of Applicability
93 Annex A controls documented - 96% implemented across all control categories
ISO 27001 Risk Treatment Plan
25 risks assessed and mitigated - 0 critical risks remaining
HIPAA Compliance
Privacy Rule, Security Rule, Breach Notification - 100% compliant
FDA 21 CFR Part 11 System Validation Protocol
IQ/OQ complete, PQ in progress - 95% validation complete
FDA 21 CFR Part 11 Electronic Signature System
Electronic signatures, audit trails, and controls - 100% compliant
FDA 21 CFR Part 11 Standard Operating Procedures
10 comprehensive SOPs covering all FDA requirements
GDPR Compliance Documentation
General Data Protection Regulation (EU) 2016/679 - Full compliance evidence
Compliance Training Program
10 training modules for all roles - Annual and quarterly training requirements
Evidence Collection System
Automated evidence collection for audit readiness - 80% automation target
Vendor Risk Assessment Framework
3-tier risk model with comprehensive vendor questionnaires
Change Management Process
4 change types with CAB approval workflow - >95% success rate target
Penetration Testing Program
Annual penetration testing, quarterly vulnerability scanning
EU AI Act Compliance
European Union Artificial Intelligence Act - Full compliance evidence