FDA 21 CFR Part 11 Electronic Records, Electronic Signatures, Scope and Application Testing Standard

EUROLAB laboratory provides testing and compliance services within the scope of FDA 21 CFR Part 11 standard. This guide is intended to describe the Food and Drug Administration's (FDAs) current thinking regarding the scope and application of section 21 of title 11 of the Code of Federal Regulations.

This standard provides guidance for 3 individuals to keep records or submit information to the FDA by meeting a requirement in a statute or other part of FDA regulations. It has chosen to keep records or send specified information electronically and is consequently subject to section 11.

We aim to enforce provisions regarding the following controls and requirements:

• Limiting system access to authorized persons;
• Use of operational system controls;
• use of authorization controls;
• Use of device controls;
• Determining that people who develop, maintain or use electronic systems have the education, training and experience to perform the tasks assigned to them;
• Establishing and complying with written policies holding individuals accountable for actions initiated under their electronic signature;
• Appropriate checks on system documentation;
• Requirements for electronic signatures.

EUROLAB assists manufacturers with FDA 21 CFR Part 11 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.