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How to Meet 21 CFR Part 11 Compliance?

By Peter Cutler on Thu, May 12, 2022 @ 08:51 AM

Topics: QMS QMS Software

QMS software helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. So, it is beneficiary for an organization to implement a documented quality management system, because meeting the customer’s requirements helps to instill confidence in the organization which leads to more customers, thus more sales. Also, meeting the organization's requirements ensures compliance with regulations and provision of products and services in the most cost and resource-efficient manner, creating room for expansion, growth, and profit. In addition, these benefits offer more advantages including reducing waste, preventing mistakes, lowering costs, facilitating, and identifying training opportunities, engaging staff, boosting loyalty, communicating a readiness to produce consistent results, and more …
To understand the importance of QMS, try to have a look at what not having a formalized quality management system means. First, it will prevent a company from obtaining contracts or doing business with top-tier organizations. And a Lack of document control will prevent a business from improving because it has no formal starting point. Without well-archived documents and data, the workforce is unorganized and lacks accountability. Also, employees who leave the company take irreplaceable information with them, leaving others to figure it out and endanger the quality of the business.
Therefore, in order to attain the entire potential of the organization, it is important to have a QMS that complies with 21 CFR part 11.

What is 21 CFR Part 11 Compliance?

21: Short for “Title 21,” is the section of the CFR that applies to food and drugs. The CFR contains 50 “titles.”
CFR: Short for “Code of Federal Regulations,” which is a coded (numbers and letters) set of laws published by the federal government of the United States.
Part 11: Scope is specific to electronic records and electronic signatures, which includes electronic submissions to the FDA.
So, it’s Part 11 of Title 21 of the Code of Federal Regulations, that sets out how a company operating in the US can use electronic quality records and digital signatures instead of paper-based documentation and ‘wet signatures’ in such a way that complies with FDA regulations. Each title of the CFR addresses a different regulated area; 21 CFR relates to Pharmaceuticals and Medical Devices and Part 11 is applicable to electronic records and electronic signatures. This part ensures that companies and organizations implement good business practices by defining the criteria under which electronic records and signatures are accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and handwritten signatures on paper. Part 11 essentially allows any paper records to be replaced by an electronic record and allows any handwritten signature to be replaced by an electronic one as well.

How Can One Meet 21 CFR Part 11 Compliance?

Below are 7 tips you can use to make sure you are compliant with 21 CFR part 11:


1- Determine Whether 21 CFR PART 11 Applies to Your Company
People who rely on paper records mostly think that their documents are protected and there is no need to be subject to 21 CFR PART 11. They also think that the paper is their master record, and it doesn’t matter what happens to it afterward (being uploaded or scanned) but in fact the moment a document is updated to a system a company is subject to compliance with 21 CFR Part 11.
Section 11.3 of the FDA defines “electronic record” to be “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.” So clearly most companies are affected.
Therefore, even if the company has a paper-based record it also probably has some updated files that need to be validated.

2- Follow 21 CFR PART 11 Data Security and Password Protection Practices
Security is a huge part of concern when it comes to 21 CFR PART 11 because it is very important to make sure the right people have access to the right documents or data. This is applicable whether you have a quality system solution or a simple folder tree, what differs is that if you opt for the folder tree you will have to apply a complicated process to check folder security. 

3- Have Clear Audit Trails for traceability
A complete history of your record-keeping system is essential so that FDA can view these records upon inspection. Audit trails should clearly show which user performed which action at what time. And if you want to have a smooth inspection you better have easy access to these records.

4- Follow 21 CFR PART 11 Guidelines on Electronic Signatures
As said previously 21 CFR Part 11 guidelines assure security on signatures and help avoid falsification of digital records of course. On the other hand, with paper there is a loophole because anyone can make changes on any paper without leaving a trace. You should note that if you intend to use electronic signatures you need to notify the FDA by sending a letter.

5- Do Not Outsource Your Responsibility
Some software platforms claim that they can take care of your 21 CFR PART 11 compliance, it will not be as efficient as you doing it yourself.

6- Validate for IQ, OQ, and PQ
You need to validate for Installation Qualification to make sure your software is installed correctly, for Operational Qualification to know if the software is capable of meeting the regulatory requirements, and for Performance Qualification to know if the software is in its best performance.

7- Consider 21 CFR PART 11 When Choosing QMS Solution
Take your time and investigate various QMS solutions considering the needs of your company when it comes to validating for CFR Part 11. Because a bad choice of QMS will cost you additional money and time.

In Conclusion, every company is recommended to consider complying with 21 CFR PART 11 and should not look at this task as a punishment but as a way to make data well organized, secured, and easily accessible with a low risk of mistakes. And having some time and resources for this task will pay off eventually in terms of quality and productivity.
It is also important to create a Part 11 compliance culture in the company making sure that everyone understands 21 CFR PART 11 and the benefits that it can bring to the company. 

What’s Next?
Now that you have learned how to meet 21 CFR Part 11 Compliance, learn more about the benefits of ISO 14001.



Peter Cutler

Written by Peter Cutler