Can a HCM module be "FDA compliant"?
By Anders Northeved on Oct 14, 2010
When people asks this question they are refering to a set of criteria released by the U.S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health (CDRH) in 1997.
This deals with "electronic records, electronic signatures (ERES), and handwritten signatures appended to electronic records are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures on paper documents".
This is also know as the "21 CFR part 11" in reference to the section of the Code of Federal Regulations (CFR) in which it is published.
The answer to the question is that a program cannot be FDA compliant - so therefore our HCM suite of programs are not "FDA compliant".
But what you CAN do is to make it easy for an organization to get FDA approval of the process in which your HCM module is a part. In order for FDA to approve a company's procedure the IT applications used in these procedures must be able to let users sign electronically when they have done certain steps.
In OLM 12.1.2 we have added eSignature functionality to make it easier for organizations to get this approval of their training processes.
Learners will have to give their electronic signature when they have finished a course; administrators will have to give their electronic signature when they create a course or update the description of the course or change the status of a learner.
In this way an organization can document (with signatures) which learners have taken which training, when it was done and what the training covered - and this is what the FDA needs.
So is OLM "FDA compliant"? No, but it is ready to be part of a FDA approved training process!