What is 21 CFR Part 11 and Why Does Compliance Matter?

April 02, 2020

If you work in the biotech, pharmaceutical or life science fields, you are likely already well aware of the complex set of regulatory frameworks that your organization must operate within.

Rightly so, the manufacturers of pharmaceuticals and medical instrumentation are monitored by the Food and Drug Administration with an eagle eye. The most often maligned of these regulations is the FDA’s Title 21 CFR Part 11, commonly referred to as simply ‘Part 11’.

With complex compliance requirements that are constantly evolving to keep pace with technological change, many view maintaining Part 11 compliance as a regulatory thorn in their side. However, with the right solution and strategy in place, maintaining Part 11 compliance can not only be easy, it can also benefit the operational efficiency of your business. So, what is 21 CFR Part 11 exactly, and why does it matter?

 

What is FDA Title 21 CFR Part 11?

21 CFR Part 11 is a regulatory framework that governs how life science, biotech, and pharmaceutical companies handle their electronic records and signatures. The regulation sets out a framework for properly managing digital records so that they meet the requirements for regulatory inspection by the FDA. While facilitating regulatory oversight is the core focus of Part 11, the driving force behind it was, in fact, to ease the cost and burden of maintaining paper records to satisfy regulators.

The history of Part 11 goes back quite a bit further than you might think. The regulation’s life began in 1991, when the project was first launched by the US Pharmaceutical Manufacturers Association in an effort to modernize their records management while still meeting regulatory standards. From there, it took six years until the final rule was codified in 1997. However, that does not mean that Part 11 has remained the same over the past two decades. There have been a number of revisions to keep the regulation aligned with modern changes in technology, such as cloud-based records management.

What Industries (and Who) Does it Apply To?

21 CFR Part 11 applies to any electronic records or signatures which are created, maintained, or otherwise processed under any records requirements as defined by the FDA. Any records that are stored, signed, or processed digitally in the course of business for a biotech, life science, or other FDA regulated company fall under the regulation. Even if the master records are maintained on paper, if duplicates are stored or shared digitally, Part 11 applies.

With regards to who is affected by the regulation, it essentially applies to any businesses operating in the US in the biotech, life science, medical instrumentation, or similar industries. Most non-food businesses that are within the jurisdiction of the FDA must meet 21 CFR Part 11 compliance, barring a few exceptions. In the modern age, maintaining a fully-paper record is not feasible or cost effective, so almost all businesses in these sectors are affected.

What are the Requirements of 21 CFR Part 11?

While the intricacies of 21 CFR Part 11 may seem overwhelming, it can actually be broken down into seven key requirements that must be met for compliance.

Limited Access

Given the regulations purview of ensuring the legitimacy of records and signatures for audit, limiting access only to authorized users is essential. Each user should be issued with a unique set of login credentials that will allow all of their activity to be identified. It is also important to be able to demonstrate the access controls in place.

Audit trails

Fundamental to all good records management, audit trails are central to Part 11 compliance. Audit trails create a system of record and support the access controls requirements with proof of operator access. Every creation, modification, or deletion of a record should be logged automatically to an audit history which cannot be modified.

Written policies

All policies associated with operating and maintaining the hardware, software, and physical records involved in the document management system of the organization should be clearly documented. These policies should be available to all operators of the system and be covered fully during training for anyone with access to the records.

Validation testing

Just like a chain, a records management system is only as strong as its weakest link. If the reporting from a system is faulty, then the whole thing fails to be effective. This is why validation testing is required to meet compliance for Part 11. FDA auditors must be able to trust the integrity of the data they are being presented with. Regular system validation checks must be conducted and logged to meet compliance requirements.

Digital signatures

The majority of 21 CFR Part 11 is focused on electronic records. However, in order to streamline activities, it also covers digital signatures. For digital signatures to be compliant, they must be “based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified."

Training

Finally, Part 11 also requires that all users with access to the system be properly trained in the protocols of operation. Users should be trained for their specific role and be made aware of the limitations of their access and responsibilities. All training should be documented fully so that auditors can easily review the operator audit trail and cross reference it with the training logs.

Risks of Non-Compliance

Since shortly after its inception, the FDA has been fairly consistent in its enforcement of Part 11, with most infractions being related to system validation and protection of records. There are three stages of action that non-compliant companies can expect to experience. They are as follows:

  1. The company will receive an FDA Form 483 after their inspection if anything is deemed to be potentially non-compliant.
  2. The FDA will issue a warning letter citing the issues of compliance and outlining next steps if compliance is not met.
  3. If compliance issues are not resolved, or if initial issues were particularly egregious, the FDA will issue a consent decree or injunction.

Injunctions or consent decrees can be hugely damaging to a product or company, potentially resulting in a ban on production or importation. However, even warning letters can result in dramatic losses in stock value when they are made public. When it comes to Part 11 compliance, the safes and most cost-effective approach is to invest early and avoid painful losses down the line.

Benefits of 21 CFR Part 11 Compliance

It is important to remember, when faced with the hurdle of Part 11 compliance, that the goal of the regulation is actually to streamline compliance and allow businesses to speed up their operations with electronic records management systems and signatures. It may feel like it is putting the brakes on your operations, but following compliance guidelines actually comes with a host of benefits. This is particularly true if you implement a software solution that is designed to facilitate 21 CFR Part 11 compliance.

Some of the benefits of Part 11 compliance are:

  • Increased operational efficiency
  • Reduced expenses
  • Improved system security
  • In-built effective employee training
  • Huge savings on storage space
  • Streamlined patent filing

 

21 CFR Part 11 Compliant Software Solutions

Despite the benefits of Part 11 compliance, implementing a fully-compliant system of records management from scratch would undoubtedly be a bitter pill to swallow. It would be hugely costly and time consuming, and would certainly throw a wrench in any ongoing product or drug development. Thankfully, navigating Part 11 compliance is not something that you have to do yourself.

There are a number of electronic records management software platforms that are built specifically with Part 11 compliance (and a number of other regulatory frameworks) in mind. Many, like the solutions available from Infolinx, even integrate digital and physical records management into one system, allowing your organization to seamlessly manage all your records in one platform. The best solutions also offer extensive training programs to ensure that your staff, as well as your systems, meet compliance adequately.

Summary

Regulatory compliance is not something that anyone is excited about tackling. However, CFR Part 11 is an essential component in protecting the industry from bad actors and slips in quality assurance. While it may feel like a chore, it is important to remember that its history is rooted in freeing the life science, biotech, and pharmaceutical industries from being tied to paper records.

 

With the right solution in place, Part 11 compliance can not only be smoothly integrated into your organizational workflow - it can be a framework for improving your operational efficiency and reducing delays and costs for your organization on several levels. With the risk of non-compliance being potentially crippling losses, investing in a solution that can guarantee CFR Part 11 compliance now could save millions in the future.

 

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