21CFR Part 11

U.S. Food and Drug Administration (FDA) compliance with 21 CFR Part 11:

Rainbow Secure supports organizations in achieving compliance with 21 CFR Part 11, a regulation issued by the U.S. Food and Drug Administration (FDA) that sets requirements for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries. Here’s how Rainbow Secure helps businesses meet 21 CFR Part 11 compliance:

  1. Secure User Authentication: Rainbow Secure provides robust user authentication mechanisms, including multifactor authentication (MFA) and strong password policies. This ensures that only authorized individuals can access electronic records and perform electronic signatures as required by 21 CFR Part 11.

  2. Access Controls: Rainbow Secure enables organizations to implement granular access controls, allowing them to define roles and permissions for different users. This ensures that individuals have appropriate access rights based on their roles and responsibilities, reducing the risk of unauthorized access to sensitive data.

  3. Audit Trails: Rainbow Secure offers comprehensive audit trail functionality, recording all user activities, including logins, access to records, and electronic signatures. This feature supports the requirement of 21 CFR Part 11 to maintain detailed audit trails for electronic records, helping organizations track and monitor user actions for compliance purposes.

  4. Data Integrity and Security: Rainbow Secure employs advanced encryption techniques to protect electronic records and ensure data integrity. It safeguards against unauthorized modifications or tampering of records, aligning with the integrity requirements of 21 CFR Part 11.

  5. System Validation: Rainbow Secure provides documentation and assistance to support the validation processes required by 21 CFR Part 11. This includes documentation on system configuration, security measures, and user access controls, helping organizations demonstrate compliance during regulatory audits.

  6. Compliance Reporting: Rainbow Secure offers reporting capabilities that assist organizations in generating compliance reports required by 21 CFR Part 11. These reports include information on user activities, system configurations, and security measures, providing evidence of compliance to regulatory authorities.

By implementing Rainbow Secure, organizations can effectively address the requirements of 21 CFR Part 11, ensuring the security, integrity, and authenticity of electronic records and signatures. This helps businesses in the pharmaceutical, biotechnology, and medical device industries meet compliance obligations and maintain the highest standards of data integrity and regulatory compliance.