Our System

Data Virtuoso, Inc. implements validation requirements of FDA CFR 21 Part 11 (Electronic Records and Signatures) in data processing, analysis and reporting . All programmers at Data Virtuoso are mandated to follow Good Programming Practices and take necessary training on SOPs and regulatory policies.

In-house Practices & Regulatory Guidelines

Database securities (password protected)
Regular database backup and remote backup
CRF tracking, lock and unlock
Employee training on SOPs and FDA guidelines
Guidelines on data imputation and modification
Preparation for an audit