Paradiso works with your company to be Part 11 compliant

The Part 11 compliance in Pharmaceutical and food companies talks about the requirements that are necessary to run properly your pharmaceutical or food services with all the regulations that the FDA (Food and Drug Administration) needs. Part 11 compliant standard is the regulation established for e-signatures, auditing, and record keeping. Regulations like the FDA request that your Learning Management System (LMS) is validated for intended use in LMS part 11 compliant.

Title 21 CFR Part 11, commonly known as Part 11 compliant regulation, is the section of the Code of Federal Regulations (CFR) that deals with Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. It defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

In order to comply with the specified regulations dictated by law, an LMS must count with specific characteristics in its system settings, such as the ability to track the events developed inside the platform. Also, it must have a compliant storage capacity and an e-signature featuring.

What’s the reason to be LMS Part 11 compliant?

This is an increasingly requested requirement from customers and prospects in the Food and drugs sector who are required to adhere to this. A Company using Paradiso LMS can be FDA CFR Part 11 Compliant.

The compliance seeks to regulate the criteria in which electronic records and e-signatures are considered reliable, safe and equivalent to physical records. For this subjects, the FDA has set a list of standards to be followed in order to have Part 11 compliant.

Could a learning platform Solution be LMS Part 11 compliant?

Any solution by itself is compliant. A validation needs to be done across an entire solution, from end-to-end. This includes the data center, the server and related appliances, and the administration of these components. This validation is necessary regardless of whether an organization is using the hardware and software on-premise or if it is hosted via SaaS.

It must be stressed that Part 11 compliance depends on both the technical controls implemented by the LMS and Company controls such as policy and procedure that must be met by the Company itself.

How does Paradiso LMS comply with the Part 11 compliant requirements?

These are only some of the requirements that Paradiso LMS has taken in the count to make sure that your company becomes Part 11 compliant. It is necessary to clarify that Paradiso LMS is not fully compliant with this regulation. This is because the e-learning industry does not need to be compliant with part 11 by itself. However, Paradiso LMS provides all the options and features necessary for your pharmacy or food company to have a properly structured LMS that complies with the laws dictated by FDA.

Rely on Paradiso Learning Management Software to run all your company’s training processes without having to worry about Part 11 compliance, we will work hand to hand with your company to reach it.

If you would like to get further information about Part 11 compliance and/or try Paradiso LMS, contact our sales team at [email protected]