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7 questions: Obtaining FDA 21 CFR Part 11 compliance in Pharma and Biotech

Estimated reading time: 4 minutes

Dive into the key aspects of 21 CFR Part 11 compliance and the guidelines for maintaining temperature records that meet requirements. 

Do you work in Pharmaceuticals, Biotechnology, or another life science industry? 
Then you have undoubtedly come across FDA 21 CFR Part 11.
In this article, we break down the pivotal elements of FDA 21 CFR Part 11 you need to know to make sure your temperature, humidity, and other environmental monitoring records and procedures live up to the standard.

Is your temperature monitoring setup preventing compliance?

Check out the article: “21 CFR Part 11 compliant monitoring systems: What to look for?”

7 questions and answers about 21 CFR Part 11

What is 21 CFR Part 11?​

21 CFR Part 11 is a regulation established by the U.S. Food and Drug Administration (FDA) to ensure the integrity, authenticity, and reliability of electronic records and signatures in regulated industries, such as pharmaceuticals and biotech. The standard says that electronic records should be “equivalent to paper records and handwritten signatures executed on paper1. In other words, it aims at ensuring the trustworthiness of digital records by treating them as equivalent to written records.

Why is 21 CFR Part 11 based on handwritten records?

The standard originated in the 90s when the FDA recognized the increasing use of digital systems.

At the time, the baseline was handwritten records, and as a result, the standard is based on the understanding that the golden standard for security and reliability must be paper.

If a standard was created today, it would likely be based on digital as the ideal, and handwritten as the deviation. 

But here we are.

Which organizations are 21 CFR Part 11 relevant for?

FDA 21 CFR Part 11 is relevant for almost all of us. The standard applies to all organizations operating in FDA-regulated industries such as pharmaceuticals, biotechnology, and medical devices and utilizes certain types of digital records – more on that in a second.

Why is 21 CFR Part 11 NOT only relevant in the United States?

Even though it is an FDA requirement, 21 CFR Part 11 applies to organizations worldwide – not just in the United States. 

If your organization is based outside the US and does not directly distribute products or operate within the US, it is not legally required to comply with FDA regulations. 

However, if your organization exports products to the US or has business relationships with US-based companies that are subject to FDA regulations, you might need to demonstrate compliance with relevant regulations.

Tip! Even if you are not obligated to comply with 21 CFR Part 11 (yet), implementing procedures that demonstrate compliance with recognized international standards will not only help you secure the quality of your product but also enhance your credibility and marketability on an international level.

What type of records does 21 CFR Part 11 apply to?

Not all entries and records in a digital system have to be compliant with 21 CFR Part 11 – so let’s talk about the ones that generally do:

  1. Electronic records that are required to be maintained under predicate rule
  2. Records in electronic format in addition to a paper format that are relied on to perform regulated activities
  3. Records submitted to the FDA under predicate rules 
  4. Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules

What are some examples of record types that fall under 21 CFR Part 11 in Pharma?

Here are six examples of records that typically need to comply with 21 CFR Part 11 requirements:

  1. Batch records: Electronic records that document the manufacturing processes and controls for each batch of a product. These records include information about raw materials, equipment used, process parameters, and quality control tests such as temperature and humidity monitoring.
  2. Laboratory data: Digital records generated in pharmaceutical laboratories, including analytical data, test results, laboratory notebooks, and instrument readings.
  3. Quality control (QC) records: Records that pertain to quality control activities, such as calibration records, instrument logbooks, stability testing data, and batch release documentation. 
  4. Complaint files: Electronic records that capture and track customer complaints, investigations, and corrective actions. This ensures the traceability and integrity of complaint-handling processes.
  5. Training records: Electronic records related to training programs, including training materials, attendance records, and competency assessments.
  6. Standard Operating Procedures (SOPs): Records related to the creation, revision, and distribution of SOPs that are maintained in digital form.

Note that the specific records subject to Part 11 requirements can vary depending on your organization, the nature of the products, and the processes involved.

What guidelines should you follow to be compliant with 21 CFR Part 11?

These are some of the key requirements of 21 CFR Part 11:

  • Security measures: Your systems should be secure and protected – this includes several aspects such as user control, authentication, and ensuring data integrity. Your user authentication mechanisms could include the use of passwords, biometric authentication, or multi-factor authentication.
  • Audit trails: Traceability is key. Clear audit trails are used to track changes made to the data. It must be clear which user made changes, and the date records were created, modified, deleted, etc.
  • Ensure data integrity: Protect against unauthorized access, data loss (back up your data), and tampering. 
  • Personal accountability: Users must be accountable for their actions, and their signatures should manifest their identity and purpose. 
  • Uniqueness and authenticity of users: Users should be unique individuals, and measures should be in place to ensure their authenticity.
  • Process documentation and review: Document and frequently review your procedures.
  • Training: Regularly train relevant personnel to ensure compliant use of your temperature monitoring system.

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