At Symfo, we take steps to ensure our eDiaries, services and processes are in strict compliance with FDA, EMEA, ICH and other Regulatory Authorities requirements, guidelines and practices. Symfo is constantly reviewing the ever changing requirements for ePRO use in collecting accurate data to ensure GCP, HIPAA and CSUCT/CSUCI guidelines, practices and regulations are followed as they relate to ePRO.
All Symfo eDiaries, services and processes fall within the spirit of FDA CFR 21 part 11.
- Symfo eDiaries are closed systems
- Password protected
- eClinical Data stored in encrypted format
- Servers are closed system with controlled access
Symfo has established an internal audit policy to ensure our customers receive the quality and services they expect and depend on. In addition to internal audits, we conduct audits of our vendors and suppliers to again ensure exceptional quality and service to our customers.