Compliance - IT Infrastructure
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.
- 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.