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AutoClean EEG: 21 CFR Part 11 Compliance

This document outlines how AutoClean EEG addresses the requirements of 21 CFR Part 11, focusing on aspects relevant to program managers evaluating the pipeline for use in regulated research or clinical trials.

Introduction to 21 CFR Part 11

21 CFR Part 11 establishes the FDA's regulations for electronic records and electronic signatures. It aims to ensure the trustworthiness and reliability of electronic data used in regulated industries, including pharmaceuticals and medical devices. Key areas of focus include:

  • Data Integrity: Ensuring data is accurate, complete, consistent, and reliable.
  • Audit Trails: Maintaining a secure and time-stamped record of all data creation, modification, and deletion.
  • Electronic Signatures: Implementing secure and verifiable electronic signatures to authenticate records.

AutoClean EEG and Part 11 Compliance

AutoClean EEG has been designed with Part 11 compliance in mind. The following sections detail how the pipeline addresses specific requirements:

1. Electronic Records

  • Secure Storage: EEG data, metadata, processing logs, and reports are stored in a secure NoSQL document database (e.g., MongoDB - specify your database). Access control mechanisms are implemented to restrict unauthorized access and modifications. (Describe your specific access control mechanisms: user roles, permissions, etc.)
  • Data Backup and Recovery: Regular backups are performed to ensure data recoverability in case of system failures. (Describe your backup and recovery procedures, including frequency and storage location.)
  • Data Retention: Data retention policies are in place to comply with regulatory requirements. (Specify your data retention policies.)
  • Data Validation: The pipeline undergoes rigorous testing and validation to ensure data integrity and accurate processing. (Describe your validation procedures: unit tests, integration tests, user acceptance testing, etc.)

2. Electronic Signatures

  • Unique User Identifiers: Each user is assigned a unique username and password for system access.
  • Signature Manifestation: When a user performs an action requiring a signature (e.g., approving a preprocessing run, releasing data for analysis), the system captures:
    • User's full name
    • Date and time of the signature
    • Meaning of the signature (e.g., "Approved," "Reviewed")
  • Signature Linking: The electronic signature is securely linked to the specific record or action within the database.
  • Non-Repudiation: The system's architecture and audit trails prevent users from denying their signature.

3. Audit Trails

  • Comprehensive Logging: AutoClean EEG maintains detailed audit trails that record all data creation, modification, and deletion events.
  • Audit Trail Content: Each audit trail entry includes:
    • Timestamp of the event
    • User who performed the action
    • Type of action performed
    • Specific data affected
  • Secure Audit Trail Storage: Audit trails are stored securely and are protected from unauthorized modification or deletion.

4. System Validation

  • Validation Documentation: A comprehensive validation plan and report are maintained, documenting the validation process and results. (Link to your validation documentation if available.)
  • Testing and Verification: The pipeline undergoes various testing phases, including unit testing, integration testing, and user acceptance testing (UAT), to ensure its functionality and compliance.
  • Change Control: A change control process is in place to manage any modifications to the pipeline and ensure that changes are properly tested and documented.

5. Training

  • User Training: All users of AutoClean EEG receive training on the system's operation and Part 11 compliance procedures. (Describe your training program: training materials, frequency, etc.)

Benefits for Clinical Trials

By adhering to Part 11 requirements, AutoClean EEG offers several advantages for clinical trials:

  • Data Integrity and Reliability: Ensures the trustworthiness of EEG data used in clinical trial analyses.
  • Regulatory Compliance: Facilitates compliance with FDA regulations, reducing the risk of regulatory issues.
  • Data Traceability: Provides a clear and auditable record of all processing steps, enabling efficient data review and analysis.
  • Reduced Risk of Errors: Automation and standardized procedures minimize the risk of human error in data processing.

Contact Information

(Include contact information for inquiries related to Part 11 compliance or the AutoClean EEG pipeline.)

This revised version directly addresses the needs of program managers by:

  • Focusing on Part 11: The entire document is centered around Part 11 requirements.
  • Explaining Key Concepts: It provides a brief overview of Part 11 for context.
  • Highlighting Specific Features: It details how AutoClean EEG addresses each key requirement.
  • Emphasizing Benefits for Clinical Trials: It explains the advantages of using a Part 11 compliant pipeline in a clinical trial setting.