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21 CFR part 11 : Electronic records and Electronic signatures

The Code of Federal Regulations (CFR) is the official codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.  

CFR is a set of regulations that govern how businesses must operate in order to protect the health and safety of employees, customers, and the general public. 

Title 21 of the CFR is reserved for rules issued by the Food and Drug Administration (FDA). Part 11 of title 21 CFR sets forth the FDA’s requirements for electronic records and electronic signatures (ERES). 

The purpose of part 11 is to establish the criteria under which are considered trustworthy and reliable and to ensure that they are properly managed and controlled.  

Part 11 also sets forth the requirements for businesses that wish to use electronic records and electronic signatures (ERES) in their operations. 

To comply with Part 11, businesses must put in place policies and procedures for managing ERES to ensure the accuracy and security of their electronic records and signatures 

What are Electronic Records ? 

Electronic records are any type of record that is stored electronically. This can include everything from emails and text messages to digital images and video files.  

Electronic records have a number of advantages over traditional paper records,  

Including the fact that they are easier to store, search, and share. They can also be more difficult to lose or damage. 

What are Electronic Signatures ?  

An electronic signature, also known as an e-signature, is a digital form of a traditional handwritten signature.  

It is used to indicate that an individual agrees to the terms of a contract or other document.  

Unlike a handwritten signature, which can be forged, an electronic signature is unique to the individual and cannot be tampered with. 

Electronic signatures are becoming increasingly popular as more and more businesses move online.  

They are faster and more convenient than traditional signatures, and they provide a higher level of security. 

How to comply with CFR Part 11: Electronic records and Electronic signatures? 

In order to comply with CFR Part 11, companies must put in place certain technical and organizational safeguards. For example,  

  1. Electronic signatures are unique and verifiable. Companies must ensure that they are accurate, trustworthy, and reliable. 
  2. Electronic records & signatures are generally equivalent to paper records. You must also put in place security measures to protect these records from tampering or unauthorized access and make them tamper-proof.
  3. Companies must maintain a system to track when and by whom electronic records and signatures are made.

Compliance with CFR Part 11 can be a challenge, but it is essential for companies conducting clinical trials and pharmaceuticals. By putting these regulations into place, companies can ensure the validity and security of the trials and production. 

What are the consequences of not complying with CFR part ? 

Businesses in regulated industries that do not comply with CFR can face a variety of consequences. It can have serious consequences for your business such as that can make it difficult to attract customers and business partners. You may be damaged to your reputation, hefty fines, legal action, or even shut down. 

In some cases, non-compliance can even lead to criminal charges. This can happen if a business is found to be willfully violating the regulations, which means that they knew they were violating the regulations and chose to do so anyway.  

It’s important to note that CFR Part 11 is not a voluntary regulation. But that is mandatory for any organization that uses electronic records in regulated industries. Failure to comply with the regulation can have severe consequences, so it’s important to make sure you are in compliance with all of the requirements. 

Batchline is specifically designed to protect the integrity of electronic records and ensure that they are accurate and reliable. 

Please get in touch to find out more about BatchLine and request a demo. 

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