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

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