The Datimbi platform has been engineered from its foundation to be FDA 21 CFR Part 11 compliant to support Good Clinical Practice (GCP).  These features also add value to enterprise data management in general:

  • Unique user ID, password-protected accounts, with password management policies
  • Role-based security that defines the system-wide and project-specific functions and privileges assigned to a user
  • All data updates (and other system events) are logged indelibly at the data field level, including the user, date/time, field definition, from and to data values, with the additional ability to provide Edit Reasons for data updates
  • Integrated data Query functionality (question/answer for data quality) at the form and field levels
  • Field edit and display privileges definable down to the field-level
  • A robust multi-organization structure that enables managers to define which collaborators can see which data records
  • A role-definable Track Changes function that enables data quality assurance staff to easily identify the set of information they need to review