Compliance & Regulatory
Last Updated: July 10, 2025
✓ Pharmaceutical-Grade Compliance
OCSR™.ai is built from the ground up to meet the stringent regulatory requirements of the pharmaceutical industry. Our platform ensures your R&D operations remain compliant while accelerating innovation.
1. FDA 21 CFR Part 11 Compliance
Our platform fully complies with FDA regulations for electronic records and electronic signatures:
Electronic Records
- Validation: Complete system validation with IQ/OQ/PQ documentation
- Audit Trails: Comprehensive, tamper-proof audit trails for all actions
- Data Integrity: ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available)
- Retention: Configurable retention policies with secure archival
- Copy Protection: Certified true copies with verification
Electronic Signatures
- Unique user identification and authentication
- Biometric options available
- Signature manifestations include printed name, date/time, and meaning
- Non-repudiation controls
- Signature/record binding that cannot be excised
2. HIPAA Compliance
Administrative Safeguards:
- Security Officer designation
- Workforce training and access management
- Access authorization procedures
- Security incident procedures
- Business Associate Agreements (BAAs)
Physical Safeguards:
- Facility access controls
- Workstation security
- Device and media controls
Technical Safeguards:
- Access control with unique user identification
- Automatic logoff
- Encryption and decryption
- Audit logs and controls
- Data integrity controls
- Transmission security
3. GxP Compliance
Supporting Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and Good Clinical Practice (GCP):
- Document Control: Version control, approval workflows, and controlled distribution
- Change Control: Formal change management procedures
- Training Records: Documented training with competency assessments
- Quality Management: Built-in quality processes and checkpoints
- Validation: Computer System Validation (CSV) support
4. International Standards
ISO 27001:2013
Information Security Management System certified, ensuring systematic approach to managing sensitive information.
SOC2 Type II
Annual audits confirming our security, availability, processing integrity, confidentiality, and privacy controls.
5. Data Privacy Regulations
GDPR (General Data Protection Regulation)
- Lawful basis for processing
- Data subject rights (access, rectification, erasure, portability)
- Privacy by design and default
- Data Protection Impact Assessments (DPIA)
- International data transfer safeguards
CCPA (California Consumer Privacy Act)
- Consumer rights to know, delete, and opt-out
- Privacy notices and disclosures
- Data inventory and mapping
- Vendor management
6. Industry-Specific Compliance
Pharmaceutical Industry Standards:
- ICH Guidelines compliance
- EMA regulatory requirements
- Health Canada compliance
- PMDA (Japan) requirements
- ANVISA (Brazil) standards
- TGA (Australia) compliance
7. Validation Documentation
We provide comprehensive validation packages including:
- User Requirements Specification (URS)
- Functional Requirements Specification (FRS)
- Design Specifications (DS)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Traceability Matrix
- Risk Assessment
8. Audit Support
We support your regulatory audits with:
- Pre-audit preparation assistance
- Audit trail reports and data packages
- Subject Matter Expert (SME) support
- Corrective and Preventive Action (CAPA) tracking
- Post-audit remediation support
9. Compliance Monitoring
Continuous Compliance Assurance:
- Real-time compliance monitoring dashboards
- Automated compliance checks and alerts
- Regular internal audits
- Third-party compliance assessments
- Regulatory update tracking and implementation
10. Contact Compliance Team
For compliance inquiries or audit support:
Compliance Team: compliance@aarth.io
Quality Assurance: qa@aarth.io
Compliance Statement: OCSR™.ai maintains a comprehensive Quality Management System (QMS) that ensures ongoing compliance with all applicable regulations. Our compliance team continuously monitors regulatory changes and updates our systems accordingly.