Choosing a Title 21 CFR Part 11 and EU Annex 11 Compliant Medical Imaging Clinical Trial Platform

Title 21 CFR Part 11 and EU Annex 11

When considering selecting a medical imaging clinical trial platform, ensuring compliance with regulatory standards is paramount. In this article we explore specifically the key aspects you should explore and validate with any potential vendor to make sure you meet the requirements of both Title 21 CFR Part 11 and EU Annex 11

Data Integrity and Security

  • Audit Trails: Confirm that the platform maintains comprehensive audit trails for all activities related to image acquisition, processing, and storage. These trails should be tamper-evident and easily accessible.
  • Access Controls: Evaluate access controls to ensure that only authorized personnel can interact with the system.
  • Encryption: Verify that sensitive data is encrypted during transmission and storage.
  • Validation Mechanisms: Assess how the platform validates data integrity consistently.

Electronic Signatures

  • Unique Identifiers: Ensure that each user has a unique electronic signature.
  • Timestamps: Validate that timestamps accompany every electronic signature.
  • Non-Repudiation: Confirm that signatures cannot be denied or repudiated later.

Validation and Qualification

  • Software Validation: Investigate how the platform validates its imaging software. Look for evidence of accuracy, reliability, and compliance.
  • User Acceptance Testing (UAT): Inquire about UAT processes to verify that the system functions as intended.
  • Change Control: Understand how the platform handles changes and updates.

Archiving and Retrieval

  • Long-Term Storage: Assess the platform’s archiving capabilities. Ensure that images are securely stored for the required retention period.
  • Data Retrieval: Evaluate how efficiently historical data can be retrieved.
  • Data Migration: Discuss plans for seamless data migration during system upgrades.

Risk Management

  • Risk Assessment: Ask about risk assessments specific to the platform. Identify potential risks related to data integrity, security, and system functionality.
  • Mitigation Strategies: Understand the platform’s risk mitigation measures.
  • Contingency Plans: Inquire about contingency plans for system failures or breaches.

What to take away

These regulatory requirements are complex and the above is a simplified intro to what to check for. Query any vendor on prior audits on the topic to build additional confidence.

Scientific articles on the same topic emphasize robust validation processes, secure data handling, and continuous monitoring. As a clinical trial study coordinator, consider collaborating closely with the platform provider, conducting due diligence, and seeking expert advice to ensure compliance.

Remember that compliance is an ongoing commitment. Regular audits and proactive risk management contribute to successful clinical trials and patient safety.


Pär Kragsterman, CTO and Co-Founder at Collective Minds Radiology


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