Generative AI and Its Impact on Validation: Part 1

21 CFR Part 11 is the section in the Code of Federal Regulations of the United States that sets forth the Food and Drug Administration’s (FDA) guidelines on using electronic records and electronic signatures. Here are some high-level user requirements that may be applicable for a system designed to meet 21 CFR Part 11 compliance:

1. Authentication: The system must be capable of ensuring that each user's identity is unique and secure. This could involve the use of complex passwords, biometrics, or two-factor authentication.
2. Access Control: The system must support role-based access control, limiting system access to authorized individuals.
3. Audit Trail: The system must have a secure, computer-generated, time-stamped audit trail to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.
4. Record Retention: The system must be capable of retaining all electronic records for the period required by relevant regulations and must ensure their integrity and confidentiality.
5. Signature Manifestation: For electronic signatures, the system must clearly link such signatures to their respective electronic records and must include the printed name of the signer, the date and time when the signature was executed, and the meaning of the signature (such as review, approval, responsibility, or authorship).
6. Signature/Record Linking: Electronic signatures and handwritten signatures executed to electronic records must be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record.
7. Validation: The system must be validated to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
8. System Documentation: The system must maintain thorough documentation, including system operation and maintenance instructions, system design and development documents, validation documentation, and any changes to the system.

Please note that this is a high-level list of requirements, and the actual set of requirements can be more extensive and should be defined based on a detailed understanding of the specific regulatory and business needs.

Below are the functional requirements for the "Authentication" aspect of a system, in accordance with 21 CFR Part 11 compliance:

Functional Requirement 1: Unique Usernames

• The system shall not allow two users to have the same username.
• Each username must be unique to ensure individual accountability and traceability.

Functional Requirement 2: Password Complexity Rules

• The system shall enforce password complexity rules. Passwords should be a combination of uppercase and lowercase letters, numbers, and special characters.
• The system should not allow commonly used or easily guessable passwords.

Functional Requirement 3: Password Expiry and History

• The system shall require users to change their passwords periodically.
• The system shall prevent the reuse of a certain number of previous passwords to discourage cycling back to old, potentially compromised passwords.

Functional Requirement 4: Account Lockout

• The system shall lock out a user account after a defined number of unsuccessful login attempts to prevent unauthorized access.

Functional Requirement 5: Biometric Authentication

• If applicable, the system shall support biometric authentication methods such as fingerprint scanning or facial recognition.
• The system should securely store biometric data and only use it for authentication purposes.

Functional Requirement 6: Two-Factor Authentication

• The system shall support two-factor authentication.
• After successful verification of the username and password, the system shall require a second form of authentication (such as a one-time password sent via SMS or email, or a push notification to a registered device).

Functional Requirement 7: Session Timeout

• The system shall automatically log out a user after a period of inactivity to prevent authorized access.

Functional Requirement 8: Secure Transmission

• The system shall transmit authentication data (like passwords, biometric data, or two-factor authentication codes) securely using encryption.

Please note that while these requirements provide a strong foundation for secure authentication, they may need to be adjusted or expanded based on the specific system, user needs, or regulatory context. Always consult with a security professional when designing authentication systems.