Transparency and fairness must prevail for electronic records and signatures to be considered valid which is where CFR Part 11 of the Code of Federal Regulations finds its relevance. While it gives companies the guidelines to do this successfully and succinctly, Oracle EnterpriseOne gives companies the platform and controls to implement it in just 15 steps. To learn more about 11CFR 21 please check out our blog article.
With that said, ERP systems have had to build this functionality into their software products to stay competitive. Oracle’s “JD Edwards Enterprise One: Governance, Risk, and Compliance” solution document lists the modalities of building an effective control system.This includes:
Oracle has provided businesses with tools to manage their auditing and electronic signatures. It takes us 15 steps to get a company CFR11 compliant if they are on the latest release.
Required Steps to Configure Table Auditing (Overview)
There are some items that require planning. For example, turning on GRC will dramatically increase your database usage. Oracle recommends using the following formula to size your database post GRC activation.
“Database size increase per audited table = audit table record size x2 (before and after image) x number of transactions.”
Whoa, that will be a massive increase. It’s time to call the SAN vendor. Is this justifiable? Yeah, it sure is, because E1’s auditing functionality is largely based on table triggers passing before and after data, time and date of the transaction and the name of the user who made the change.
A few general rules must be understood:
There are 3 applications which help to control this functionality.
And, there are 3 reports which produce a printable report of the audit and signature information.
Schedule Ad Hoc
The schedule of this task greatly depends upon your timetable. Contact us to check our availability.
Estimated Time 30 Hours
We’ve implemented this recently for a multi billion dollar company. Including planning, meeting & training sessions, it took us 30 hours.
Estimated Cost $2,310