I. System Documentation and Gap Analysis A. Review 21 CFR Part 11 Requirements: Directly read and extract key points from the regulation that apply to software systems. B. Document Current System Architecture: Use tools like diagrams and flowcharts to document your current system setup, including databases, APIs, and user interfaces.
II. Software System Validation A. Develop Validation Protocols: Create automated tests to validate all functions related to electronic records and signatures. B. Keep Validation Reports: Store validation results in a structured format (e.g., JSON, XML) along with timestamps and version information.
III. Implement Security Measures A. Implement Access Controls: Use AWS Identity and Access Management (IAM) to set up user roles and permissions. B. Integrate Data Encryption: Apply encryption to data at rest using AWS services like Amazon S3 and data in transit with SSL/TLS protocols. C. Enable Audit Trails: Use AWS CloudTrail and other logging tools to record all system usage and data access changes.
IV. Controls for Electronic Records A. For Closed Systems: Ensure that only authenticated and authorized users can access the system using multi-factor authentication. B. For Open Systems: Implement API gateways with rate limiting, logging, and secure authentication (e.g., OAuth2).
V. Manage Electronic Signatures A. Integrate Electronic Signatures: Use services like AWS KMS for managing cryptographic keys that secure digital signatures. B. Ensure Signature-Record Linkage: Develop functionality to unequivocally associate signatures with their specific electronic records, preventing any tampering.
VI. Conduct Regular Compliance Audits A. Schedule Automated Security Scans: Use tools like AWS Inspector or third-party security services to perform regular security assessments. B. Review and Update Security Policies: Regularly update security policies based on audit findings and emerging threats.
VII. Developer Training on Compliance A. Participate in Online Courses: Enroll in courses specifically about 21 CFR Part 11 and AWS security best practices. B. Document Learning Outcomes: Keep a log of completed trainings and their key takeaways relevant to your systems.
VIII. Preparation for FDA Inspections A. Organize Documentation: Maintain an organized repository (e.g., using GitHub or Bitbucket) of all compliance-related documents and codebases. B. Mock Inspections: Periodically practice mock FDA inspections with an internal or external auditor to ensure readiness.
Created on 5/6/2024