Electronic Records / Electronic Signatures (ERES)

The acronym ERES stands for "Electronic Records & Electronic Signatures". 

What is Title 21 CFR Part 11? 

Title 21 CFR Part 11 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 and handwritten signatures executed on paper. Even though the guideline was developed in the United States, it is widely accepted in Canada as well.

What Does It Mean?

Organizations like healthcare providers, pharmaceutical and medical supply that fall under the 21 CFR Part 11 guidelines need to take extra precautions when using an LMS (Learning Management System) to disseminate information. Part 11 requires that both procedural controls (e.g. notification, training, SOPs, administration), and administrative controls are put in place by the you (the “Client”), in addition to the technical controls that a vendor (“Dual Code”) can offer.

What Electronic Records / Electronic Signatures Does Dual Code Generate?

The Dual Code LMS comes complete with an LRS (Learning Record Store). The LRS is the authoritative database that logs all learning records. A learning record looks as per the following:

John Smith completed WHMIS on December 31, 2018

Once a learning record is stored in the LRS, it can never be altered or deleted. While administrators with special permissions can void learning records, these records can always be recovered by unvoiding them.

Only records stored in the LRS are considered “electronic records” or “electronic signatures” as per 21 CFR Part 11. Other types of records stored in various components of the LMS may or may not meet all of the guidelines and as such, should not be considered valid “electronic records” or “electronic signatures”.

What Does Dual Code Do To Support Title 21 CFR Part 11?

Complying with the 21 CFR Part 11 guidelines requires that the whole solution meets the guidelines. This includes not only the LMS / LRS provided to you by Dual Code, but also the courses and learning material that you, the Client, will be uploading to the LMS.

The Dual Code team has the technology, software, and expertise to ensure you remain in compliance with Title 21 CFR Part 11. While we cannot guarantee compliance simply because we do have control over all of the requirements, Dual Code can help you stay within the guidelines. 

To learn more about ERES compliance or to get a copy of our "ERES Compliance Checklist", please contact us.