Built for regulated life sciences environments

1. FDA 21 CFR Part 11 Support

Electronic records and signatures designed for regulated use

Accura provides system capabilities designed to support compliance with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures.

Key controls include:

• Secure, role-based electronic signatures
• Signatures linked to identity, timestamp, and record context
• Tamper-evident audit trails for all regulated actions
• Controlled record lifecycle management
• Access controls aligned with user roles and responsibilities

2. ALCOA+ Data Integrity

Ensuring trust in regulated data

Accura is designed to support ALCOA+ principles for data integrity across quality and laboratory processes.

Data captured in the system is:

• Attributable to a specific user
• Legible and human-readable
• Contemporaneous with the activity
• Original or securely linked to original source
• Accurate and validated within system controls

3. GAMP 5 / CSA-Aligned Validation Approach

Modern validation principles for cloud-native systems

Accura is designed in alignment with modern validation approaches, including GAMP 5 and evolving Computer Software Assurance (CSA) principles.

This approach supports:

• Risk-based validation strategies
• Focused testing of critical system functionality
• Reduced reliance on documentation-heavy validation cycles
• Continuous evidence generation through system operation

4. ISO & Laboratory Framework Alignment

Designed for laboratory and medical environments

Accura is suitable for use in environments operating under:

• ISO 13485 (Medical Device Quality Management Systems)
• ISO 15189 (Medical Laboratories)
• ISO/IEC 17025 (Testing and Calibration Laboratories)
• GMP-aligned manufacturing environments

5. Data Security & Residency

Control over sensitive regulated data

Key capabilities:

• Role-based access control (RBAC)
• Secure authentication and access management
• Encrypted data storage and transmission
• Full audit logging of system activity
• Configurable data residency (including Australian hosting options)

6. Audit Trail & Traceability Model

Every action is traceable and verifiable

Accura maintains a comprehensive audit trail across all regulated system activities.

The system captures:

• User identity
• Timestamped actions
• Before/after state changes
• Workflow transitions
• Approval and signature events