Systems Management – Safety Database Approach and Best Practices
Validated safety systems are essential for the effective and compliant management of Serious Adverse Events (SAEs)/Individual Case Safety Reports (ICSRs) and regulatory submissions in clinical trials and post-marketing surveillance. Systems management ensures GxP compliance, data integrity, and operational efficiency across the pharmacovigilance lifecycle.
Date: 01 August 2025 | Ref: ART002
Aixial’s Safety Database Approach
Aixial’s safety database is an industry preferred safety system ‘LifeSphere MultiVigilance (LSMV)’, founded by ArisGlobal with over 30 years of safety expertise, and is actively used across hundreds of organisations globally. LSMV is a multi-tenant cloud-based platform which ensures compliance with the latest regulations and can deliver out-of-the-box availability of capabilities.
This document outlines best practices for operational oversight of the safety system lifecycle management, grounded in Computer System Validation (CSV) aligned to applicable regulations and standards (e.g., 21 CFR Part 11, ICH E6 R3). LSMV is hosted, maintained and validated by ArisGlobal and additionally, the system is validated for use through User Acceptance Testing (UAT) by the dedicated Aixial pharmacovigilance team using a risk-based approach.
System Implementation and Validation
- Deploy safety systems within a controlled project framework including user requirements specification, requirements traceability matrices and functional specifications.
- Assure and maintain procedural alignment to available system functionality at implementation and across the delivered system software updates.
- Conduct risk assessments to determine operational / regulatory impact and validation scope, documenting rationale for testing coverage.
- ArisGlobal execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Aixial execute Performance Qualification (PQ) tests based on user requirements specification with traceability matrices linking requirements to test evidence.
- Validate data migrations to ensure end-to-end data integrity, especially when transitioning from legacy platforms.
Configuration Management
- Maintain Configuration Specifications (CS) documenting configuration records including application parameters, report parameters, data rules, edit checks, workflows and data privacy rules.
User Access Management
- Enforce role-based access controls (RBAC) to ensure users have only the permissions necessary for their responsibilities.
- Perform periodic access reviews to maintain security and compliance.
- Document all user account provisioning and inactivation activities.
System Maintenance and Change Control
- Operate under a structured change control process, reviewing release notes, capturing impact assessments and testing when appropriate.
- ArisGlobal schedule updates and maintenance to manage version control and downtime.
System Security
- ArisGlobal use ISO27001 data hosting centres with assured logical and physical access controls, firewalls, vulnerability management and intrusion detection.
Audit Trails and Data Integrity
- Ensure the system generates comprehensive, regulatory compliant audit trails capturing creation, modification, and deletion of records, including user IDs and timestamps.
Case Processing and Reporting
- Implement standard operating procedures (SOPs) covering consistent case intake, triage, data entry, quality review, medical coding, and regulatory submission workflows.
- Medical and product coding through MedDRA and WHODrug Global
- Generation of Regulatory Report Forms such as MedWatch 3500A and CIOMS I.
- Configuration of reporting pathways (E.G. to EudraVigilance, FDA ESG, MHRA Gateway) to confirm accurate, timely transmission of ICSRs.
Generation and Provision of Data Listings
- Integration with LifeSphere Reporting and Analytics (LSRA) to generate standard reports (E.G. DSUR Listings) or custom reports in various formats (E.G. PDF, Excel).
Business Continuity and Backup
- ArisGlobal ensure backup and retention defined frequencies and durations are documented and tested regularly.
- Disaster Recovery Plan (ArisGlobal and Aixial), Business Continuity and Cloud IT Service Continuity are documented.
Training and Competency
- Deliver role-specific training for all system users, maintaining training records in accordance with GCP and GVP requirements.
- Provide refresher training following major system updates, process changes, or regulatory updates.
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