Compliance - IT Infrastructure

Compliance

SCiAN's software and our internal IT environment have been designed to meet the regulatory requirements set forth by FDA 21 CFR Part 11 and FDA Guidance for Computerized Systems Used in Clinical Trials. Our system development follows SciAn's software development life cycle.

We provide support to our clients to ensure compliance of their study configuration to the study protocol, regulations and ICH E6 Guideline for Good Clinical Practices.

Our project managers work with you to ensure your study EDC configuration meets your needs.  We test your configurations to ensure it meets your specifications prior to your review and approval. Changes to your configurations are managed through our change management process.

IT Infrastructure

  • FDA 21 CFR Part 11 compliant IT environment
    • System and software validation
    • Procurement & decommissioning
    • System setup / installation
    • System maintenance / upgrades
    • Incidence and change management
    • Failover / Co-Hosting
    • Backup, disaster recovery, business continuity
    • System access & security: physical, network, server, application, record and field-level
  • Periodic independent 3rd party audits.