PaperFeed Enterprise - Your Solution for FDA CFR Part 11 Title 21 Compliance

Safeguarding Your Business with FDA's 21 CFR Part 11 Compliant Document Management Made Simple with PaperFeed Enterprise

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Published on July 10, 2023

PaperFeed Enterprise - Your Solution for FDA CFR Part 11 Title 21 Compliance

At, we go beyond merely stating our commitment to regulatory compliance. We deliver it. Our Enterprise solution is meticulously engineered to satisfy the stringent requirements of the FDA’s CFR Part 11, Title 21, providing a secure, reliable, and fully compliant document management system for your business.

Document Control Enterprise facilitates robust management of electronic records, ensuring the preservation, authenticity, confidentiality, and auditability of your documents as demanded by the FDA. Our platform supports legally binding electronic signatures, each associated with a unique user ID, to validate the integrity of your electronic records and to comply with 21 CFR Part 11’s stipulations.

Comprehensive Audit Trails

Transparency is key to regulatory compliance. That's why our Enterprise solution implements comprehensive, system-generated, time-stamped audit trails. These trails record every modification to your electronic records, including who made the change and when it was made. This ensures traceability and accountability in line with 21 CFR Part 11 requirements.

System Validation

Recognizing the critical role of system validation in CFR Part 11 compliance, we ensure our software's consistent intended performance through rigorous validation processes. Our Enterprise solution guarantees that every feature works as expected in your specific operational environment, helping you uphold system integrity and protect your invaluable data.

Controlled Access Enterprise delivers robust user-level access control, in full accordance with 21 CFR Part 11. With our system, you can allocate unique user IDs, enforce secure passwords, and utilize two-factor authentication to prevent unauthorized system access. Furthermore, you can define user roles and permissions, ensuring only authorized personnel can access sensitive data.

Data Integrity and Protection

In line with FDA's ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) principles of data integrity, we offer advanced error detection and prevention mechanisms. Additionally, we provide reliable data backup and recovery systems to protect your electronic records from potential alteration, loss, or inadvertent destruction.

Education and Support

Our commitment to compliance extends to user training. We provide extensive education and continuous support to ensure all users can proficiently navigate and utilize the system, in line with 21 CFR Part 11 requirements.

Ongoing Compliance Assurance

With Enterprise, staying up to date with evolving regulatory standards is effortless. We consistently review and update our system to meet changing guidelines, ensuring your document management system remains in compliance with 21 CFR Part 11.

Choose Enterprise – a document management solution that doesn’t just promise FDA compliance, but delivers it. With us, you can confidently focus on propelling your business forward, knowing your document management practices adhere to the highest regulatory standards.

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