Validation of Regulated Clinical Systems
Information Technology /
Validation of Regulated
Clinical Systems

TRI not only considerably improves your regulatory records management, publishing, and submission processes through commercial and custom solutions, we also perform ongoing quality control and validation of any software and systems involved in your clinical trial to guarantee total compliance with national and international regulatory frameworks.

Key Services

  • Validation of Regulated Clinical Systems
    • Core validation services focus on 21 CFR Part 11 compliance but extend to provide clients with confidence in the integrity and accessibility of their web-based systems with additional checks for:
      • Accessibility (Section 508, WCAG 1 and 2)
      • Legal Compliance (US, CAN-SPAM, EU Privacy, Trademark and Copyright)
      • Search Optimization for Public Systems
      • Standards Compliance (W3C HTML/XHTML & CSS)

We protect your data and content such as records, documents, and e-signatures, by validating your system’s procedures, controls, and security features while maintaining your supporting technologies’ functionalities and performance. We inspect and validate all clinical applications, systems, software, hardware, and web-based platforms, especially those sed to create, store, modify, maintain, and transmit electronic records and manage signatures. TRI’s IT and QA experts, certify your system’s compliance with the FDA’s General Principles of Software Validation and Good Clinical Practice (GCP) guidelines by guaranteeing and maintaining your system’s reliability, traceability, accountability, integrity, and security through ongoing evaluation from initiation to disposal. For example, we ensure that your system possesses appropriate security and authority checks to prevent unauthorized access and/or alteration, that it includes time-stamped audits trails monitoring entries and recording data's creation, modification, and disposal, and that the users have been thoroughly trained. Finally, we provide strategic planning by defining clear testing plans, coding standards, change control procedures, system reviews, and draft comprehensive policies and protocols that will govern your systems’ functionalities and operational utilizations.

TRI goes beyond compliance with 21 CFR Part 11 with the delivery of additional validation services including authentication of W3C markup standards conformity for your website’s compliance and quality purposes, accessibility assessment, and global legal compliance evaluation. We ensure accessibility and compliance with the section 508 of the Rehabilitation Act by verifying that your device, software, systems, and web-based platforms eliminate barriers to information technology for people with disabilities and provide solutions along with a set of alternatives to auditory and visual content. We also confirm compliance with the Web Content Accessibility Guidelines (WCAG) 1 and 2 by ensuring respect of its technical standards, guidelines, and testable criteria for the web content to be perceivable, operable, understandable, and navigable. Finally, we certify compliance with national and international Intellectual Property laws including with trademarks and copyrights regulations, as well as confirm proper adherence to privacy laws concerning the use of commercial email, commercial messages, and opt-out rights as described in the U.S CAN SPAM Act and the data protection requirements defined in the European Union and Federal Privacy Laws.

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