Demystifying the process of complying with 21 CFR Part 11

There’s been a lack of clarity around what’s needed to comply with 21 CFR Part 11, the US Food and Drug Administration’s regulations for inspecting electronic training records held by organizations.

Implementing electronic signatures and being able to clearly audit their use has often been a considerable challenge for businesses in the life sciences and pharma sectors.

This is an essential requirement for companies in these sectors looking to comply with the FDA’S CFR regulations. In-depth and rigorous auditing is increasingly sought-after by organizations in other sectors too, such as healthcare.

A photo of a person sitting at a laptop holding a bottle of manufactured pharma drugs as an illustration of the pharma 21 CFR Part 11 regulation

How a more detailed level of reporting leads to 21 CFR Part 11 compliance

Fortunately, the right compliance LMS makes creating and documenting deep audits and analysis straightforward.

NetDimensions Talent Suite, for example, offers an extensive variety of steps to make your auditing more effective.

A photo of a screen from an elearning course showing various types of learner data reports as part of compliance with the pharma 21 CFR Part 11 regulation
Enabling CFR functionality (left) generates extra reports

Once you’ve turned the appropriate esignature and auditing capabilities on, you can easily examine who’s made changes in your system, such as whether an admin has marked a learner’s progress as complete.

NetDimensions already provides you with requests such as course launches, user log-ins and log-outs, user and certificate deletions and enrollments. In addition, enabling the functionality for CFR compliance in NetDimensions Talent Suite generates a number of extra reports. These include:

  • Audit trail reports
  • Audit trail user action reports
  • Learning module audit reports
  • User transcript audit reports

 

Taking the hassle out of producing effective reports

There are a huge number of audit items you can choose to monitor in NetDimensions Talent Suite. These are accompanied by a wide range of options within each item you can create an audit trail report on.

This means you can drill down into your course activity on a granular level to meet almost any part of a regulatory request. That’s everything from enrollment date and assessment grade, to reminder counts and total time spent on the curriculum.

A photo of a screen from an elearning course showing various types of learner data reports as part of compliance with the pharma 21 CFR Part 11 regulation
You can choose to select a range of items for audit trail reporting

You can narrow down reports by date and search for specific users. From the individual user panel, you can see what actions your learners and system managers took.

These include launching a course, editing an external training record or finishing a course, with a precise timestamp accompanying each action.

Auditors require businesses to demonstrate which learners have carried out what actions. They need to see that these learners have read and understood course content.

They usually require this information to be made available in PDF format, which is one of the options offered by the selection of different output formats we make available to L&D teams.

Tailored analysis to manage the data you see

Audit log listing, which allows you to turn on full audit logging, comes out of the box with NetDimensions Talent Suite. In version 13.2, we also introduced a learning transcript history, available under system configuration.

This allows L&D professionals to see who has carried out what actions on a learner’s account. It also gives learners full visibility of any changes made to their account.

A photo of a screen from an elearning course showing various types of learner data reports as part of compliance with the pharma 21 CFR Part 11 regulation
Audit trail reports show individual actions such as launching and completing a course

What’s more, you can choose when esignatures and full auditing are turned on. And they can be applied only to specific cohorts of learners and users. Esignatures can be enabled at the course, class or level.

For example, you might want to capture when learners from a particular department withdraw from a course. Or you may need to know when learners in a certain office complete a module.

Auditors often want data to be presented in a specified format, such as sorted by first or last name. NetDimensions Talent Suite lets you configure the format in which this information is captured.

What’s the difference between authentication and validation?

Authentication and validation are vital for organizations looking to verify data and prove the integrity of their training. However, it’s important to understand the difference between the two.

Validation relates to ensuring that all the different steps and processes in a system work in the way they were designed in order to create valid data.

Authentication, meanwhile, is about ensuring that the user is who they claim to be.

Complying with 21 CFR Part 11 is an authentication process. It confirms that specific people have completed actions in compliance training in order to meet regulatory requirements set out by the FDA, and ensures that electronic records and signatures are trustworthy and reliable.

But you can’t achieve effective authentication without validation. Authentication through esignatures, for example, needs to be carried out on software that has been validated.

Even though implementing esignatures is an important step towards authentication, turning them on doesn’t mean your system is validated. Validation means testing each part of the system and making sure you can follow its processes to demonstrate that it does what it says it can do.

No solution alone can be compliant, as validation is an end-to-end process. But a system such as NetDimensions Talent Suite meets all of the requirements in order for you to achieve clear validation without expending unnecessary resources in an overly complex process.

In cases where you require further assistance, NetDimensions also provides consulting services for NetDimensions Learning LMS to be validated in client environments.

A photo of a group of healthcare professionals looking at a computer screen as an illustration of the pharma 21 CFR Part 11 regulation

 

Want to ensure your training records are ready for an audit to meet 21 CFR Part 11 compliance? Discover how NetDimensions can help get you up-to-date and inspection-ready.

If you found this blog useful and want to know more about how NetDimensions can help transform your Learning Management System, contact us today.

 

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