Datatrak International clinical research software, medical, coding, autocoding, devices, medical coding programs, workflow document management software, clinical trial collection, 21 cfr part 11, dicom

quality assurance
Your success is our goal

DATATRAK Quality Management System

We define “quality” as our ability to fulfill our customers’ expectations--not only the expectations for our products, but for all services in connection with doing business with DATATRAK. Specifically, our quality understanding ensures that we strive to:

Meet or exceed customer requirements
Continuously improve our process, people and product
Be on time, within budget, & meeting profitability goals for our shareholders
To enable employees to achieve these objectives, DATATRAK has initiated a clearly defined Quality Management System (QMS), which is geared to be in compliance with all the relevant Global Regulations affecting our industry.

This QMS forms a rich foundation for our internal processes. By adhering to our Quality Policy and the related procedures, DATATRAK will maintain the status of a “Quality Endorsed Company.” The independent auditing process, as required by the above-mentioned standards, confirms that our QMS complies with the predefined global quality and regulatory standards.

DATATRAK Software and Services Compliance

DATATRAK software development and services for clinical studies are based on clearly defined lifecycles.

Continuous activities by our Department of Quality Assurance, combined with customers’ audits, guarantees compliance development and validation of our software products and related processes. Specific areas related to electronic data and our staff, include:

GCP
FDA’s 21 CFR Part 11
FDA GFI: “Computerized Systems used in Clinical Investigations”

Services

Regulatory Authorities

FDA
ICH
EMEA

CLICK HERE for a Replay of
DATATRAK Presents at the Roth Conference Wednesday, February 20