What is 21 CFR Part 11? FDA requirements explained

WTH is FDA 21 CFR Part 11? That’s a question many medical device developers wanting to access the US market must have asked themselves - in one way or another.

It’s easy to be intimidated by the slew of schedules and initials you’ll be confronted with when trying to break this huge and powerful marketplace, so here’s a guide to help you understand what Part 11 really means for you.

What is CFR 21 Part 11?

It’s Part 11 of Title 21 of the Code of Federal Regulations, of course.

But put simply, Part 11 sets out how a company operating in the US can set up an FDA compliant, digital Quality Management System using electronic records and e-signatures in place of paper-based documentation and ‘wet signatures'.

Why does it matter?

First published in 1996, there have been various iterations of Part 11 released over the years to keep up with changes in technology and the way companies want to develop their products.

Part 11 was the FDA’s response to the opportunities and challenges of the information age. As other industries were reaping the benefits of increased digitisation, medical device developers were still losing time chasing multiple real-world signatures and collating paper documents to pass FDA audits.  

In Part 11 the FDA addressed the need for increased innovation in the industry’s working methods so that new products could be brought to market faster with the help of digital tools. But it balanced this with the need to retain the highest level of authentication and control around approval processes for what are, potentially, lethal products. 

Does 21 CFR Part 11 apply to me, then?

Almost certainly. Any developer releasing a product in the US who thinks they won’t be subject to the regulation because their ‘master copies’ of documentation are all in paper form, are probably mistaken. If you store or have uploaded any of your documents onto any computer system as part of your development process it is almost certain the regulations will apply to you.

Part 11 makes life easier (honestly)

The good news is that implementing Part 11 should make your process more efficient.  It will help you develop a compliant and paperless QMS; ultimately giving you the tools to deliver safer and more effective products in a more streamlined way.

Even so, the bar for digital compliance is set extremely high. And for some, the challenge often seems too daunting, with many developers choosing to maintain their paper-based systems rather than face the upheaval of a complete digital overhaul.  

It’s true that the tools, processes and procedures you’ll need to meet the regulation are highly exacting. It will take time to set them up and validate they’re working as they should be. But once you’ve done so, you’ll be able to collaborate more efficiently and effectively across your business and more easily demonstrate to the regulator you have built your products to the required standards.

With that in mind, here are 7 ways FDA CFR 11 works to make your medical device development process more secure, transparent, and effective.

7 critical requirements for 21 CFR Part 11

1. Data integrity

Part 11 requires that you have the digital process and controls in place to ensure the  “authenticity, integrity, and, when appropriate, the confidentiality of electronic records”.

The point of the regulation is to make sure the data and information you collate and share as you build your product is accurate, traceable, fit for purpose, and protected from loss or misuse. Imposing all the controls required by Part 11 will minimise the risk of product failure, preventing harm to end-users and the expense of correcting mistakes or paying fines for compliance breaches. It’s a sound investment.

2. Data retrieval

Part 11 says you should have the tools to protect your documentation “to enable their accurate and ready retrieval throughout the records retention period.” Controlling the records from your development process so they are automatically archived, indexed and available on-demand will help you:

• Audit your own system effectively to investigate and proactively check for non-conformities and issues
• Track and trace ‘root causes' of any identified non-conformities in your system
• Support external audits - respond quickly to regulatory questions to keep your business compliant

3. Validation

Part 11 requires:

“Validation of systems to ensure accuracy, reliability, [and] consistent intended performance"

In other words - you should formally define how all elements of your system are supposed to work, then develop scripts and test routines to validate it is functioning as it should. Although it can feel burdensome, the process of validating your QMS will demonstrate it is fit for purpose and give you and the regulator confidence that you are able to deliver products to the required standard.

4. Audit Trails

Part 11 requires you to have a complete version history available for every quality document in your system, through the:

“Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records.”

Recording the detail of every change and sign-off event by author, date, and time will give you complete traceability and accountability over all the decision-making that happens in a development process. It will make for faster and more precise auditing and investigative processes than using a paper-based system.  

5. Operational Controls

Part 11 requires the “Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate.”  

The ability to set up automated workflows for the collection of approvals and signatures will give you more control over people and process as you manage the development cycle.  They can ensure key documents are grouped together before they are reviewed by specific individuals at specific moments in your plan.  Part 11 helps bring order and clarity to potentially complex processes and minimises the risk of a business making costly mistakes.

6. Security Controls

Part 11 specifies the controls you need over access and editing rights within your system. The regulation includes many exacting requirements to prevent the accidental loss and deletion of data, as well security breaches that can result in customer harm, commercial failure and attract regulator fines.

7. Electronic signatures

The requirements for the use of electronic signatures are famously mapped out in Part 11.

Part 11 specifies that e-signatures applied to documents must include the printed name of the signer, the date/time the signature was applied, and the ‘meaning’ or intention of the electronic signature as part of an evolving and uneditable audit trail.  But the requirements do not stop here.

In trying to match the level of legal confidence offered by a ‘wet signature’, Part 11 has made the authentication requirements for digital approval way more stringent. The processes you’ll need in place to ensure identity authentication and protection from falsification require high levels of digital document control and workflow management to achieve. Right now, it would be significantly easier to falsify a pen and ink signature on a test result, than to do the same with an electronic signature under the FDA rules.  

But in spite of the challenge, the benefits of ditching wet signatures are obvious.  Gathering signatures remotely, rather than in person, can reduce admin time from days or weeks to hours and minutes. Meanwhile, the levels of accountability and trackability an e-signature solution can deliver will make future investigation and auditing tasks much less difficult and time-consuming.

For medical device developers who are seeking to enter the competitive and lucrative US market, it makes sense to find an electronic Document Management System (eDMS) flexible and powerful enough to cope with the technical demands of 21 CFR Part 11 as you build your quality system.  It will help to make what could be a nightmarish process of digital compliance quicker and much, more straightforward.

But the truth is, it’ll be worth the investment for many other reasons, too. The right solution will bring new levels of rigour and efficiency to your entire development process, helping you save money, build better products and control the risk of failure.

Last updated on 02/11/2022