Electronic Records and Electronic Signatures (ERES) in OLM

Oracle E-Records is a configurable framework for secure capture, storage, inquiry, and printing of electronic records and electronic signatures (ERES) in compliance with government regulations.

For more information about Oracle E-Records, see: Oracle E-Records Implementation Guide

OLM uses the electronic records and electronic signatures (ERES) functionality of Oracle E-Records to enable organizations meet legislative compliance, such as the United States Food and Drug Administration (US FDA) Code of Federal Regulations (CFR) Title 21 Part 11, otherwise known as 21 CFR Part 11.

Using the electronic records and electronic signatures functionality, you can obtain electronic signatures for the following business transactions:

You can use Oracle E-Records Evidence Store to query electronic records and electronic signatures. See: Retrieving Electronic Signature Records

This topic explains how:

Enabling Electronic Signature at the Course Level

You enable electronic signature when you create a course by selecting the Enable electronic signature check box. When you select this check box for a course, OLM applies the electronic signatures feature for learners, administrators, and instructors at different stages of learning.

You cannot disable electronic signature for a course if any one learner enrolls into a class.

How the Electronic Signature Functionality Works

Electronic signature when an administrator changes course description, course name, or course code

If the electronic signature is enabled for a course, then when an administrator updates the Description, Course name, or Course Code on the Update Course page and clicks Apply, OLM displays the E-signatures page.

On the E-signature tabbed region, as an administrator select the signature type, which is the type of signer, for example, reviewer or author. Select a Response, which is either Approve or Reject. If you select Approve, then OLM saves the course updates when the electronic signature process is completed. If you select Reject, then OLM does not save the changes when the electronic signature process is completed. Enter any comments, if applicable. Enter your user name and password to sign the document. Click the Sign icon to complete the signature process. The E-Record tabbed region displays a record of the course changes that you make.

Electronic signature when an administrator or instructor changes the enrollment status

On the Update Enrollment Status page, when an administrator changes the enrollment status of learners in a class that is part of a electronic signature enabled course and clicks Apply, OLM displays the E-signatures page.

On the E-signatures tabbed region, as an administrator select the signature type, which is the type of signer, for example, reviewer or author. Select a Response, which is either Approve or Reject. If you select Approve, then OLM saves the changes when the esignature process is completed. If you select Reject, then OLM does not save the changes. Enter any comments, if applicable. Enter your user name and password to sign the document. Click the Sign icon to complete the signature process. The E-Record tabbed region displays a record of the enrollment status change that you make for the class.

Administrators cannot set the enrollment status of a learner directly to Attended in a class that is electronic signature enabled. The administrator can set the enrollment status to Pending Signature to obtain the electronic signature of the learner.

Note: If a class requires learners to provide electronic signature and complete an evaluation, then set the status to Pending Signature and Evaluation. Learners must first provide their electronic signature and then complete the evaluation.

When the administrator performs a mass update of enrollment statuses, OLM saves the electronic signature together with one e-record for each one of the learners whose status is updated. Instructors must also provide electronic signature if they change the enrollment status.

Electronic signature when a learner completes a class

Online Class: When a learner completes the last learning object in a class with electronic signature, the Learner Home page displays the signing icon in the Evaluate or Sign column. When the learner clicks this icon, OLM presents the E-signatures page. On the E-signature tabbed region, the learner can select the signature type and must select the approve or reject response type. OLM saves the learner's electronic signature record if the learner selects the Approve response type. The learner must enter user name and password, and click the Sign icon to provide electronic signature. The E-Record tabbed region displays the electronic signature record details.

Scheduled Class: After the learner participates in a class, the administrator or instructor can change the enrollment status to Pending Signature. When the learner clicks the signing icon in the Evaluate or Sign column, OLM presents the E-signatures page. On the E-signature tabbed region, the learner can select the signature type and must select the approve or reject response type. OLM saves the learner's electronic signature record if the learner selects the Approve response type. The learner must enter user name and password, and click the Sign icon to provide electronic signature. The E-Record tabbed region displays the electronic signature record details.

Retrieving Electronic Signature Records

Use the ERES Administrator responsibility to retrieve the electronic signature records. In the ERES Administrator responsibility, click the Evidence Store function. The E-record Details page stores all the e-records created for an organization. Search for e-records using the event name, for example, OLM ERES Course Update or signer name.

OLM provides the following events for which you can search the electronic signature records:

In the search results table, click the event name. You can print e-records to meet legislative requirements.