The key to 21 CFR Part 11 Compliance

The Security Supply Chain plays a crucial role in digital security compliance. This article will explore how the supply chain helps with CFR Part 11 and the steps required to become compliant.

Anirban Banerjee
Dr. Anirban Banerjee is the CEO and Co-founder of Riscosity
Published on

What is CFR part 11

21 CFR Part 11 is a set of regulations issued by the U.S. Food and Drug Administration (FDA) that establishes the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records. In order to sell products in the United States, companies must demonstrate that their systems meet the standards set forth in Part 11. This can be a daunting task, as the requirements are numerous and detailed. However, compliance with Part 11 is essential in order to sell products in the U.S. market.

In general, 21 CFR Part 11 requires that electronic records and signatures be maintained in a manner that ensures their security, accuracy, integrity, confidentiality, and availability. Additionally, companies must put into place policies and procedures to ensure that electronic records and signatures are appropriately controlled and used only by authorized individuals. Furthermore, companies must have systems in place to verify that electronic records and signatures accurately reflect the intended actions or transactions of the individual using them. Finally, companies must establish auditing controls to track changes made to electronic records over time.

Meeting all of these requirements can be challenging for companies selling products in the United States market. However, failure to comply with 21 CFR Part 11 can result in FDA enforcement actions against a company, including recall of products, seizure of products, civil monetary penalties, and/or criminal prosecution. Therefore, it is essential that companies selling products in the United States ensure that their systems meet the requirements of 21 CFR Part 11.

What is the security supply chain

A security supply chain is a set of processes and technologies used to secure sensitive data and private information. Security features such as dual passwords, password expiration, encryption, and certification help to keep data safe. In order for pharmaceuticals and medical devices to be compliant with 21 CFR Part 11, all parties involved in the electronic signature process must be compliant with the security supply chain. This includes the MSB, the issuing and signing party, and the certificate authority.

How security supply chain helps with CFR Part 11

Step 1: Understand what CFR Part 11 is

CFR Part 11 is a set of guidelines that dictate how electronic records and signatures can be considered trustworthy. In order to sell devices in the United States, medical device developers must adhere to these guidelines. The security supply chain is integral to meeting CFR Part 11 standards, as it helps to ensure that products meet necessary safety and security requirements.

Step 2: Know the compliance requirements

In order to be CFR Part 11 compliant, the following steps must be completed:

  • Identify all computer systems used in your clinical trial.
  • Make sure the data being entered into electronic databases is accurate and reliable.
  • Get assurance from an outside source that the laboratory is accredited and using quality equipment.
  • If using an electronic database, it must be compliant.
  • If using electronic logs, they must be compliant.
  • Compliance with CFR Part 11 is an ongoing process – choose a QMS that complies with CFR Part 11, and make sure it comes with pre-validated templates.
  • Invest in a QMS solution – one that offers everything you need to bring your device to market, including validation for CFR Part 11.

Step 3: Have a clear plan

To ensure compliance with CFR Part 11, you must develop and implement a clear plan. This plan should include an analysis of which computer systems are being used in your trial, how data will be quality controlled and verified, and what electronic logs will be kept. You should also contact the Office of Compliance Services to discuss any questions or concerns about your system.

Step 4: Don't outsource responsibility

The security supply chain helps with CFR Part 11 compliance by automating workflows and imposing the required controls. These controls help prevent product failures, which can lead to harm to end-users and fines.

Step 5: Establish clear audit trails

In order to establish clear audit trails that will be useful for traceability, it is important to take note of the date and time of every operator entry and action. This way, you will have a complete history that can be used to track decision making. Clear audit trails are also essential for investigating any potential security breaches.

Your platform should assign a role to each user who can access the audit trail feature. This makes it easy to understand who did what and when. Audit trails should be recorded with the username, date, and time so they can be easily located and reviewed.

Making sure your audit trail is well-organized and easy to read is crucial for a smooth inspection process by the FDA. They will expect to be able to view your audit trail during their inspection of your facility.

Step 6: Follow guidelines on electronic signatures

Compliance with 21 CFR Part 11 is essential for companies using electronic records and signatures. The regulation specifies the requirements for companies that choose to use digitized systems in their compliance efforts.

21 CFR Part 11 regulates the use of electronic signatures. The Electronic Records section details the procedures and controls applicable to electronic records. To follow 21 CFR Part 11 guidelines, electronic signatures must be authenticated and valid. The controls listed in the Electronic Signatures section of the regulation are meant to ensure the authenticity and validity of electronic signatures.

Step 7: Validate for IQ, OQ, and PQ

CFR Part 11 compliance can be validated through a process of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). This process defines how all elements of the system are supposed to work and then develops scripts and test routines to validate that the system is functioning as it should. Validation is important to ensure that the quality management system (QMS) is fit for purpose and compliant with CFR Part 11. Although the validation process can be burdensome, it will ultimately show that the QMS is effective.

Step 8: Choose the right QMS solution

When it comes to 21 CFR Part 11 compliance for medical device development, it is important to have a quality management system (QMS) solution in place that can help with collaboration across business functions, product quality, regulatory documentation and traceability of products. A QMS can also be regularly audited and updated to help ensure compliance with FDA CFR 11.

The benefits of using security supply chain

21 CFR Part 11 compliance provides increased data confidentiality, integrity and accessibility. This standard also promotes more paperless environments and faster information exchange through the use of digital signatures and encryption. Implementing 21 CFR Part 11 can help reduce errors, increase collaboration across businesses and enhance quality assurance processes. In addition, complying with FDA regulations helps to reduce the risk of regulatory penalties or disputes. Below are the 6 key benefits.

1. Reduced errors

The security supply chain helps with CFR Part 11 compliance by providing electronic records and signatures that are compliant with the 21 CFR Part 11 regulations. This can help reduce the burden of compliance for organizations, as well as streamline the process of managing paperwork. By implementing 21 CFR Part 11 you reduce the chances of making errors which can lead to safety issues or product defects.

2. Clear audit trails for traceability

Audit trails are important for CFR Part 11 compliance because they provide a clear record of who did what and when they did it. This is important for ensuring that only authorized users have access to data, and that data is not tampered with. Audit trails should include the username, date, time, and what was changed.

3. Data retrieval

The security supply chain provides many benefits for CFR Part 11 compliance, including the ability to easily retrieve data, regularly back up data to prevent loss, and keep data safe.

  • The data must be meaningful: The data retrieved by the software must be useful and meaningful to the user.
  • The data retrieval should be easy: Users should be able to easily obtain the data they need from the software.
  • Back up data regularly to prevent loss: Data must be backed up on a regular basis to avoid losing it.
  • Keep data safe: Data must be backed up in case of a disaster or theft.

4. Data integrity

  • The security supply chain ensures the authenticity, integrity, and confidentiality of data. This prevents product failure and fines.
  • The security supply chain reduces the risk of product failure. This minimizes the risk of harm to end-users and the expense of correcting mistakes or complying with regulations.
  • The security supply chain is a sound investment. It requires validation for instruments used in data collection/analysis to ensure accuracy, fit for purpose, and more.

5. Easily comply with 21 CFR Part 11

The use of security supply chain for CFR Part 11 compliance offers a number of benefits, including reducing the burden of paperwork and formally reflected in the regulation. Additionally, it allows for the widest possible use of electronic technology and provides more confidence when complying with the regulation.

6. Mitigate manual tracking

21 CFR Part 11 compliance can make life easier for researchers working in regulated environments by reducing the need to manually keep track of paperwork. The FDA encourages the use of electronic records to reduce the amount of paperwork that needs to be manually processed. A well-formed and easy-to-read explanation in short passages about “How 21 CFR Part 11 compliance can make life easier for researchers working in regulated environments” using all the research would provide an understanding of how complying with this rule can save time and resources.


The world of compliance is growing more complex by the day. To stay ahead of the curve, it’s important to keep up with all the latest regulations and standards. One of these standards is CFR Part 11—a set of requirements that businesses must follow when acquiring or using sensitive data. If you want to make sure your company is compliant with this requirement, then you need to understand how the security supply chain can help. In this guide, we will explain exactly what a security supply chain is and why it’s such an important part of complying with CFR Part 11. We also provide tips on how to use a security supply chain for optimal results. Finally, we wrap things up by providing some advice on common mistakes business owners make when implementing a security supply chain.


What are some common mistakes made in CFR Part 11 compliance

One of the most common mistakes made in CFR Part 11 compliance is choosing the wrong quality management system (QMS). A QMS that is not specifically designed for CFR Part 11 compliance can be difficult to configure and maintain, and may not offer all of the features and functionality required for compliance. Another mistake is failing to properly track and monitor the safety and efficacy of medical devices. Adverse events must be reported in a timely manner, and companies must have a process in place for responding to these reports.

How can I ensure my company is CFR Part 11 compliant

The CFR Part 11 compliance requirements are a set of standards that must be met in order to market a device in the United States. These standards include authenticating the identity of users and notify the FDA of the intention to use an electronic system. Compliance can be achieved by implementing these requirements manually, but this can be time-consuming and costly. There are many QMS solutions available that offer everything you need to meet CFR Part 11 compliance standards.

What should I do if I’m not CFR Part 11 compliant

CFR Part 11 compliance requirements are designed to ensure that medical devices are developed securely and effectively. FDA CFR11 works to achieve this by requiring risk assessments, product characterization, design reviews, product testing, validation of clinical investigations, post-marketing surveillance and adverse event reporting. Implementing Part 11 will help your process be more efficient and help you develop a compliant QMS.

Is CFR Part 11 compliance mandatory

CFR Part 11 compliance requirements are designed to ensure the security and accuracy of electronic records and signatures. The requirements are challenging to meet, but the benefits are worth it. Implementing Part 11 can make your process more efficient and secure. You’ll need to have a plan for implementing the requirements and keep track of electronic documents and signatures throughout the project life cycle. Choosing the right QMS is important for CFR Part 11 compliance. Your solution should offer everything you need to bring your device to market. The free checklist includes steps you can take to achieve CFR Part 11 compliance..