Technical

Where is the Datimbi Platform hosted?

The Datimbi Platform is hosted in the data centers of a leading global infrastructure provider.  Data centers are located in North America, Europe, and Asia.  Customers may request their preferred regions for their Primary and Backup sites.

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What general security measures are in place?

The Datimbi platform has been constructed to maximize security and data protection, and has undergone extensive security testing through an independent external testing firm.  It is only through this type of process that customers trust their most sensitive data to us, such as medical records for clinical trials.

All connections to the Datimbi Platform, including […]

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What features are in place that make the Datimbi Platform FDA 21 CFR Part 11 compliant?

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 […]

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What else makes the Datimbi Platform GCP validated, and what is the advantage of that to your customers?

In addition to application functionality that meets the data management and QA requirements of clinical trials and medical records management, our software development lifecycle management (SDLC) process includes:

An overall documented software engineering management process
Full documentation chain, from requirements through technical design
Externally-run and verified test cases
Comprehensive system management documentation and standard operating procedures

What this means […]

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