Title 21 CFR Part 11 : Trivia Questions On FDA Guidance For Industry! Quiz

Signed electronic records shall contain information associated with the signing that clearly indicates the printed name of the signer, the date and time when the signature was executed, and the meaning associated with the signature. This ensures that there is a clear record of who signed the document, when it was signed, and the intention or purpose behind the signature. Including all of this information provides a comprehensive and reliable record of the signing process.

21 CFR Part 11 is a regulation that sets forth the requirements for electronic records and electronic signatures in the pharmaceutical and healthcare industries. It requires the validation of computer systems to ensure their accuracy, reliability, and consistency. Additionally, it mandates controls for both open systems (systems that are accessible by multiple users) and closed systems (systems that are limited to a specific group of users). Therefore, the correct answer is "All of the above" as all these requirements are necessary to comply with 21 CFR Part 11.

Those who develop, maintain or use electronic records/electronic signature systems require education and training to perform their assigned tasks. Education provides them with the necessary knowledge and understanding of electronic records and signature systems, while training equips them with the practical skills and techniques needed to effectively utilize these systems. By having both education and training, individuals can confidently and efficiently carry out their responsibilities in relation to electronic records and signature systems.

The correct answer is "The people responsible for the content." Under Part 11, the responsibility for controlling the content of a closed system lies with the individuals who are accountable for that content. This means that those who have the authority and ownership over the content are the ones who control it. The IT department may have a role in managing the technical aspects of the system, but the ultimate control over the content rests with the content owners. Users may have access to the system, but they do not have control over the content.

An example of an open system is the Internet. The Internet is a global network that allows communication and information sharing between different devices and networks. It is accessible to anyone and allows for the exchange of data, resources, and services. It is not limited to a specific organization or network, making it an open system.

The correct answer is "b and c" because both the intranet and the learning management system (LMS) on the intranet are examples of closed systems. A closed system is a computer network or software that is only accessible to authorized users within a specific organization or group. The internet, on the other hand, is an example of an open system as it is accessible to anyone with an internet connection. Therefore, options b and c are the only ones that fit the definition of a closed system.

21 CFR Part 11 became effective in August 1997. This regulation was introduced by the U.S. Food and Drug Administration (FDA) to establish guidelines for the use of electronic records and electronic signatures in the pharmaceutical industry. It aimed to ensure the integrity, authenticity, and reliability of electronic records and signatures used in FDA-regulated activities. By setting these standards, the FDA sought to encourage the adoption of electronic systems while maintaining the same level of trust and reliability as paper-based systems.

Validation of systems is required for closed systems because it ensures that the system is functioning correctly and meets the intended requirements. This process involves testing and verifying the system's components, operations, and performance to ensure that it operates reliably and securely. Validation helps to identify and mitigate any potential risks or vulnerabilities in the system, ensuring that it can be trusted for its intended purpose. Without validation, there is no assurance that the system will function as intended and meet the necessary control requirements.

Additional measures to be considered for open systems include document encryption. This is because open systems are more vulnerable to security threats and unauthorized access. Document encryption ensures that sensitive information is protected by converting it into a code that can only be deciphered with a specific key or password. This helps to prevent unauthorized individuals from accessing or tampering with the documents. By implementing document encryption, organizations can enhance the security of their open systems and protect sensitive information from potential breaches.

In an open system, nobody controls the content. Open systems are designed to allow users to freely contribute and modify content without any central authority or control. This means that the responsibility for the content lies with the users themselves, who have the freedom to create and edit the content as they see fit. This decentralized approach ensures that no single entity has ultimate control over the content, promoting collaboration and inclusivity among users.