Key Requirements Outlined in CFR Part 11

History, Evolution, and Applicability of Part 11

First published in 1996, Part 11 has been evolving to keep pace with technological changes and the manufacturing processes that go into developing the products. It reduces the documentation burden on medical device manufacturers, who earlier struggled to get signatures from authorized signatories on paper documents to pass FDA audits. The later versions facilitated the use of digital tools to speed the time-to-market while ensuring appropriate authentication and control to get the necessary approvals to ensure the quality and safety of the products.

The regulation applies to any life sciences company releasing its products in the US and for any relevant documents stored on the computer system during the development, even if paper copies are available in hard copy. Pharmaceutical, biotechnology, medical device manufacturers, clinical laboratories, developers, manufacturers, testers, or distributors of FDA-regulated products can benefit.

21 CFR Part 11 is categorized into subparts A, B, and C based on the three primary areas it applies to:

Subpart A—General Provisions: This section defines the scope and applicability of the clause, providing key definitions for the terms used in the regulation.

Subpart B – Electronic Records: It delineates the requirements for creating, modifying, and maintaining electronic records, with controls and procedures to ensure the data is secure, audit trails have been implemented, and system access is limited as per authorization needs.

Subpart C—Electronic Signatures: This part is focused on the use of electronic signatures and outlining their proper use, including implementing controls for identification codes and passwords.

21 CFR Part 11 addresses not only text-based documents but also graphics, data, audio, pictorial, or other information created, modified, maintained, archived, retrieved, or distributed by a computer system as per 21 CFR 11.3(b)(6).

Benefits of Implementing Part 11

Implementing Part 11 will improve the medical device manufacturer’s efficiency and aid in developing a compliant and paperless QMS. This will streamline processes, minimize delays, and ensure the delivery of safer and high-quality products.

Some of the benefits of 21 CFR Part 11 for medical device manufacturers include:

• Data integrity: Part 11 requires the medical device manufacturer to put in place digital processes and controls that ensure that the electronic records are authentic, have integrity, and confidentiality is protected. This ensures that the developers have access to information that is fit for purpose, traceable, and cannot be misused or lost. misuse, and reduce the risk of product failure.
• Data Access: While all documents must be protected, they must also be accessible with proper authentication and retained for the period specified by the regulation. This requires the automatic archival, indexing, and on-demand availability of the records for processes such as auditing, root cause analysis, etc.
• Audit Trails: One of the challenges of paper-based documents is version control. It is possible to preserve version history in electronic documents using time-stamps that provide audit trails. This improves traceability and accountability, facilitating precise auditing and investigations while demonstrating compliance.
• Operational Efficiency: Documents can be organized better in digital format, and automated workflows set up to obtain approvals and signatures by grouping key documents for review by authorized personnel at appropriate stages in the development cycle. This enhances visibility and minimizes the risk of costly errors.
• Improved Security: The documents that need review and approval are critical for the organization and must be protected from prying eyes. Therefore, controls must be implemented to provide access and editing rights only to authorized personnel with sufficient authentication.
• Improved Workflow Processes: The ability to use authenticated digital records and signatures reduces the reliance on manual paperwork and improves efficiency.
• Streamlined Collaboration: Data can be shared more easily across teams, departments, and sites, accelerating decision-making while smoothing workflows.

Stringent Requirements of Electronic Signatures

Part 11 imitates the stringent conformance to legally binding requirements when allowing e-signatures in electronic documents. The document must contain the following information:

• Printed name of the signer
• The date/time it was signed
• Purpose

In addition to the three requirements, it also stresses authenticating the identity of the signee to prevent falsification.

Use Compliant Software for Managing Electronic Records

A cloud-based quality management system such as ComplianceQuest facilitates the creation, maintenance, and secure access of electronic records in life sciences companies. ISO-compliant, it is already aligned with FDA requirements and helps manufacturers streamline their workflows around electronic document lifecycles.

Part 11 allows manufacturers to opt between a closed system, which requires authorization to access the records, or open systems with specific requirements with limited access to particular documents to authorized users. ComplianceQuest facilitates the creation and sharing of Standard Operating Procedures (SOPs) and training documents around Part 11 to improve the accountability of the individuals handling the electronic system.

The system enables the validation of the records system, ensuring it is secure and reliable. You can also use the system to create certified copies, maintain audit trails, and archive records.

It enables collaboration between remote teams and staff for quick reviews and approvals, also providing an audit trail for transparency and visibility. When the required storage period is over and the document becomes obsolete, the system creates notifications for the next best action based on regulatory requirements.

To learn more about the ComplianceQuest Quality Management System, visit www.compliancequest.com.