As an educational technologist, chances are you are not in this field out of your love for data traceability or your passion for ensuring your information architecture delivers rule-abiding storage and retrieval of digitally-signed historical records. But the fact of the matter is, compliance and interaction with authorities is part of the daily grind. To their benefit, they exist for a reason. In the larger scheme of things, they seek to advance your organization further, and the value of the industry to the rest society, notwithstanding the odd occurrence of bureaucracy that drags and muddies the entrepreneurial vision.
Paradiso Solutions’ Daniel Parr discusses the implications of the infamous “Part 11” on the procurement and management of Learning Management Systems. US corporations subject to regulation by the Food and Drug Administration have reportedly struggled for decades with the section in the Code of Federal Regulations, Title 21, related to “Electronic Records and Signatures.” The breadth of the ruling, which has allowed for constant complaints about its ambiguity, does have clear implications for enterprise systems where data exchange and communications take place, Learning Management Systems included. The regulations are intended to allow companies to transition from paper-based to electronic record-keeping without compromising the ability of authorities to audit data. The law defines certain requirements that are supposed to ensure such a system. They mainly include:
- “Auditability” and data preservation
- Electronic signing
- Electronic storage
- Version control
- Secure access and hosting
Sound learning experiences are the bread and butter of an LMS, but they must also tend to the regulatory needs of the industry they are reaching out to. Providers of learning systems and platforms often gain a “legal know-how” from their experiences in dealing with compliance. GDPR is likely to awaken regulators around the world, and Part 11, first signed in 1997, looks like a great reason for enforcers to get back in the saddle. And if they do, a little compliance proactivity goes a long way.
Read “The Part 11 Compliance on E-learning Systems” at paradisosolutions.com.
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