Is it any wonder more and more pharmaceutical companies are turning to digital tools to manage regulated processes? These systems streamline workflows and operations to reduce risks whilst improving efficiency. Better still, they help companies comply with key regulations, such as FDA 21 CFR Part 11.

When it comes to compliance, FDA 21 CFR Part 11 is a big one. With its focus on data integrity, audit trails, system access, and trained users, compliance is key for businesses in the American market if they want to avoid fines, market withdrawal, reputational damage, or even license revocation.

We’ll break down key requirements of FDA 21 CFR Part 11, and, best of all, share our Ultimate Guide to how TenForce helps you stay compliant.

What is the FDA 21 CFR Part 11?

21 CFR Part 11 is an FDA regulation that sets criteria for using electronic records and signatures. It covers electronic records that are created, modified, maintained, archived, retrieved, or transmitted under FDA requirements.

This regulation applies to any pharmaceutical company in the U.S. using electronic systems for recordkeeping and signatures. Its main goal is to ensure the integrity, authenticity, and reliability of these electronic records and signatures in FDA-regulated activities.

What are the key requirements of the FDA 21 CFR Part 11?

• Electronic records: Validate your system, ensure records are easy to access, control access, maintain audit trails, check operations, and provide security with encryption and digital signatures.
• Electronic signatures: signatures should be unique, securely managed, and linked to the right records. To be valid and legally binding, signatures must follow specific rules to ensure that the signer is really who they say they are, the signature isn’t tampered with, and the document is authentic.
• Audit trails: Implement secure audit trails to document changes chronologically, including who made the changes, when, and what was changed.
• Operational controls: You should ensure your system has operational checks to verify that events follow the correct sequence and prevent errors and fraudulent activities in your electronic records. Use automated workflows for document creation and approval.
• User authentication and authorization: Ensure only authorized individuals can access, create, modify, or approve records with robust authentication processes.
• Training: Make sure all your system users have the right education, training, and experience for their tasks. And document this training well.
• Validation: Validate electronic systems to ensure they meet requirements, perform as intended, and maintain data integrity.
• Data integrity: Implement controls to prevent unauthorized changes or deletions and keep records accurate and reliable.
• Security: Protect records from unauthorized access, alteration, or destruction using both procedural safeguards, like access controls, and technical safeguards, such as encryption.
• Record retention and retrieval: Ensure records are available for FDA inspection, review, and copying throughout their retention period.

For full details, and to ensure compliance, refer to the official information in the FDA 21 CFR Part 11 regulations.

What are the benefits of using a digital tool?

• Better data integrity: protecting the integrity of electronic records helps you generate accurate and reliable data throughout the record lifecycle, supporting data analysis tasks such as key metric monitoring and continuous improvement.
• Regulatory compliance: compliance helps you avoid serious repercussions such as warning letters, fines, and penalties, product recalls or import alerts, legal action, reputational damage, and increased scrutiny from the FDA.
• More efficient processes: a digital system simplifies electronic recordkeeping and signatures, saving you time, resources, and manual effort.
• Closer collaboration: a compliant system enables authorized users to share information across departments and locations, ensuring a controlled environment for project collaboration and data exchange.
• Improved auditability: track electronic records and signatures with time-stamped, computer-generated audit trails, reducing errors, ensuring traceability and accountability, and supporting accurate investigations.
• Increased security: strong security measures like access controls, user authentication, and data encryption help you protect sensitive information from unauthorized access, ensuring data confidentiality.
• Simplified recordkeeping: eliminate paper records and cut storage costs with a compliant document management system. Easily manage, access, and retrieve electronic records, improving your data accessibility and long-term retention.

How does TenForce support your compliance with 21 CFR Part 11?

Meeting 21 CFR Part 11 guidelines is easier with a digital document and process management system like TenForce. Our eQMS software simplifies compliance, unifying your quality and manufacturing goals to turn regulatory compliance into a competitive edge. Download our Ultimate Guide to 21 CFR Part 11 Compliance to see exactly how we can help:

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