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Published: May 19 2021

FDA 21 CFR Part 11 Compliance

Title 21 CFR: The Umbrella of FDA Compliance

The U.S Food and Drug Administration (FDA), the Office on National Drug Control Policy (ONDCP) and the Drug Enforcement Agency (DEA) all use Title 21 Code of Federal Relations (CFR) to govern food, drugs, cosmetics and other public health products. When it comes to enforcement, inspections can be conducted for the purpose of pre-qualification, routine inspection, or “for-cause” to investigate a specific problem reported to the FDA – so you need to be consistently ready.

Title 21 CFR, Part 11

Title 21 CFR Part 11, in particular, is all about electronic signatures, electronic records, and ensuring that both components are trustworthy, reliable and equivalent to paper records (ERES). Generally speaking, part 11 applies to medical device manufacturers, drug makers, biotech companies, and other FDA-regulated industries.

This focus on electronic records may seem oddly specific, but establishing a trustworthy, consistent electronic paper trail is a major time-saver and necessary for maintaining record standards in a modern age. Before part 11 was established in 1997, institutions had to submit physical documents to be audited, and it cost a lot of time, physical space and efficiency. Part 11 makes it much easier to prove compliance and to comply with other regulatory sections. It also helps organizations:

  • Trace changes to data.
  • Prevent or detect falsified records.
  • Understand how to effectively use computer systems and software.
  • Ensure that approval and review signatures cannot be disputed.
  • Ensure that data isn’t corrupted or lost.

That said, it’s still difficult to get right. Having electronic signatures and records that are up to regulatory standards requires audits, system validations, electronic signature software, and systems that can help store, organize, and process the electronic data that must be maintained.

Tips to Comply with Title 21 CFR Part 11

1.Make Sure 21 CFR Part 11 Applies to Your Company

According to section 11.3, the term “electronic record” is defined as, “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.” This is a broad definition that shows that Part 11 will apply to many companies.

For this reason, even if you have paper-based systems, it’s likely that 21 CFR Part 11 can apply to your business.

2. Follow 21 CFR Part 11 Password Protection Best Practices

Part 11 is ultimately all about data security and the security of your electronic records. Facilitating compliance, then, will require that you follow security practices and set the right roles and permissions when it comes to your data. It also requires effective password protection.

3. Validate for IQ, OQ and PQ

Most validation projects follow the IQ, OQ, PQ process for system validation. This, of course, stands for installation qualification, operational qualification and performance qualification. The process can ultimately demonstrate that:

  • The installation of the facility, product line, equipment, and systems are installed with a high degree of quality assurance and in accordance with all FDA quality requirements.
  • The quality of the production process meets FDA standards.
  • The quality of the documentation about the process and equipment meets FDA standards.

It’s important to get right, and the right FDA compliance software can help.

4. Create Clear Audit Trails

If you have a clear and accurate audit trail, it can make the entire auditing process easy and intuitive. This can help with part 11 compliance because it can allow your team and auditors to understand, at a glance, when records were created, changed, deleted or superseded.

To get this right, you need comprehensive change management processes.

5. Make Sure Your Compliance is Properly Handled

The responsibility of Part 11 compliance will always fall on your shoulders – and, since you’re ultimately responsible, you should be the one crossing your T’s and dotting your I’s. That said, in-house validation is often costly, time-consuming and complex – particularly as regulations change over time.

The right validation-as-a-service system, like Meridian Cloud for Life Sciences, can help take the majority of the validation process of your plate using features like:

  • Pre-validated Meridian implementation  
  • Templated validation documentation  
  • Customer-specific validation documentation modifications   
  • Data migration (test and production)  
  • User acceptance testing  
  • Deployment, with the execution of the OQ and data migration protocol  

Additionally, Accruent will be there every step of the way from system design through deployment. Then, once your system is deployed, Accruent Managed Services (AMS) will provide your team with ongoing support in the form of:  

  • Re-validation of the core solution for each Quarterly Release 
  • Templates updated, if necessary 
  • Re-testing of core solution  
  • Risk assessment of changes relative to your configuration (assigned a risk level of 1, 2 or 3)  
  • Re-validation on level 3 items against your configuration

This not only saves time but also decreases your team’ IT burden and frees up time for the execution of other business-critical tasks.

6. Follow All 21 CFR Part 11 Electronic Signature Guidelines

Many best practices for reviewing and approval information can facilitate compliance with CFR Part 11’s electronic signature guidelines. This includes features like:

Controlled Workflow 

When a user wants to make a change to a controlled document or submit it for review in Meridian Cloud, they initiate a controlled workflow to make that change. This forces documents to move through a defined workflow that requires users to pass through pre-defined review and approval steps. This helps maintain compliance and ensure that all boxes are checked.

Electronic Signatures 

In Meridian Cloud for Life Sciences, electronic signatures are required when a GMP document is put into a workflow. Each person that must provide their electronic signature will receive an email letting them know that there is a document ready for their review. As each user reviews or approves the document, their electronic signature is manifested on the PDF rendition of the document in the order they signed. This not only helps ensure that the right people see the document but also simplifies document management and streamlines the audit trail.

Electronic Print Stamp 

Every time you view, modify or print a GMP document in Meridian Cloud for Life Sciences, a print stamp and watermark will be automatically generated by the system on each PDF rendering of the document to provide key timing information. This can help maintain consistency of work across time zones and help employees understand, at a glance, which document is the latest and most up-to-date version.

7. Choose the Right QMS Solution

Compliance is a complex, ongoing process – and getting it right will be much easier with the right tools in place. When it comes to your QMS software, this should be a tool -- like Meridian Cloud for Life Sciences – that is pre-validated and fully aligned with CFR part 11.

Learn more about Meridian Cloud for Life Sciences.

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