Sep 17, 2013

SOP Training is Now “On-Line” But Are We Any More Compliant?


by Vivian Bringslimark, President, HPIS Consulting, Inc.

Well, I’m told we are now more compliant with ensuring that only the most current SOP version is used for training. And yes, our Learning Management System provides us with curricula updates and “percent complete” and “percent overdue” notifications. LMSes and eDoc systems have given us efficient mechanisms to document that employees have completed their training curricula. But do they understand their procedures enough to perform them correctly back on the job? Just look at our human error deviations and training-related CAPAs. Are the numbers declining? According to an excerpt from the PDA’s Pharmaceutical Sci-Tech Discussion Group, there is “almost a 100% correlation between the percentage of read and understood SOPs and the number of compliance issues the company has.” (1) Has efficiency become the new metric for training and compliance? Using technology to read SOPs doesn’t guarantee learning transfer.

It’s still “Read and Understand” SOPs!

Whether we access our SOPs through an eDoc system or the LMS portal, we are still only reading them. To call this eLearning is a bit of a stretch especially when compared to the design of today’s eLearning courses. Nonetheless, some new hires are still being provided with a long list of required SOPs and trained on where to find them in the LMS. “Oh,” I’m told, “but we’ve made it easier for them to manage their SOP list. They’re online now!”
My response: access is only one part of completing the requirements. A new hire needs to have optimal training experiences with a qualified trainer using a structured and deliberately planned approach to completing his/her assigned curricula. Yet, we ask our least experienced employees to “read and understand” a massive list of department SOPs with little to no prior experience and wonder why the learning curve is so lengthy! 

Sep 5, 2013



by Victor Gill, MasterControl Inc., Senior Product Manager of Cloud Solutions 

What exactly is Cloud? Or is it, The Cloud? Is it just me, or do no two people describe it the same way? As the product manager over the Cloud initiative at MasterControl, I hear these kinds of questions all of the time. With all of the advertising, mixed messaging, technical jargon, and promises of grandeur, it’s easy to see why so many consumers are confused. At its heart, the term Cloud has been a powerful marketing turn-of-phrase that has consolidated a large mix of technologies.

The general idea for the Cloud can be traced back to two simple business principles:

1. Focus on your core competencies. If you’re in the business of pharmaceuticals, medical devices, or manufacturing, you probably should avoid being in the business of creating software, managing servers, and the like.

2. Specialization improves performance and can generate economies of scale. If a company specializes in the production, maintenance, and operation of software and a sufficient number of customers chose that company’s services, the service level to the customer will be better than they could create themselves. In a nutshell the Cloud takes what software companies do best - create and maintain software - and gives access to what they have created via a wide area network, like the Internet.