21 CFR Part 11 Electronic Records and Signatures Regulation – 20 Years On

This year is the 20th anniversary of the publication of Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11 or just Part 11), the US Food and Drug Administration (FDA) regulation about control of electronic records and electronic signatures for computerised systems used by pharmaceutical and medical device companies. This is a relatively small regulation (less than 2 complete pages of the Federal Register) that has had and continues to have a big impact on regulated organisations and software suppliers.

When implementing computerised systems, the requirements of Part 11 need to be fully understood. To help this, I want to explore the following areas in this blog post:

  • What is Part 11?
  • Interpretation of Part 11 by the applicable predicate rule
  • Understanding the technical, procedural and administrative controls of the regulation
  • What is software validation?
  • Why do I need to validate my LMS?

Is your LMS secure?

Data breaches not only embarrass an organization and damage its customers’ confidence; they are costly as well – according to the 2016 Cost of Data Breach Study: Global Analysis published by IBM and Ponemon Institute in June, the average total cost of a data breach globally increased from $3.79 million in 2015 to $4 million in 2016.

The average total organizational cost of a data breach in the US this year is $7.01 million (2015: $6.53 million), in Germany, $5.01 million (2015: $4.89 million), and in the UK, $3.95 million (2015: $3.70 million). And those numbers don’t include the potential reputation damage an organization can suffer in the marketplace once word of the breach spreads.

 

LMS Security Matters

icn-data-security-solutionsNot surprisingly, protecting important data stored on organizational IT systems is a key concern of many executives. In addressing application security management it is critical that organizations should not overlook their Learning Management Systems (LMSs).

NetDimensions and Moody’s Analytics Win Gold at the 2016 Learning Technologies Awards

Moody’s Analytics, a risk management solutions provider to global capital markets, and NetDimensions won the Gold award for the Best Enterprise Learning Platform Implementation category at the 2016 Learning Technologies Awards.

best-enterprise-lms-implementationMoody’s Analytics implemented the NetDimensions Talent Suite in order to deliver innovative training solutions to financial sector organizations worldwide.

Client Snapshot: Norton Healthcare Improves Compliance & Overcomes Workforce Challenges

Norton Healthcare started as a modest, faith-based, largest integrated healthcare system in Kentucky with more than 14,000 employees at five hospitals, 13 Norton Immediate Care Centers and 90 physician practice locations. The organization has become a leading healthcare provider with some of the most advanced technologies and well-trained physicians, nurses and staff.

 

The Search for the Best Learning Management System

As Norton Healthcare’s training and compliance needs had long exceeded the capabilities of their existing Learning Management System (LMS), they embarked on an initiative to identify a new provider.

5 Challenges Faced by China in the Supply and Demand for Pilots

I attended the China Aviation Training Forum 2016 in Beijing on October 18-19. This two day forum presented some interesting insights into the challenges facing the aviation industry in China, especially in terms of the supply and demand for pilots.

china-aviation-training-forum-2016

Over the next two decades, fast growth in China’s domestic market will make it the largest domestic market in the world, and air traffic within Asia is set to become the largest travel market.[1] More than 1.5 billion passengers are expected to travel by air within China in 2035, almost four times the number of passengers in 2015.[2]