Electronic Regulatory Compliance Training: a Combined Solution for the Life Science Industries

Compliance with the FDA, the ISO, the EMEA, CLIA and additional regulatory bodies has long been a habit for successful life science companies. However compliance--like the unfortunate cat--can be skinned in more ways than one.

The Problem
Regulated life science companies are required to manage and record essential training processes which include those processes devoted to regulatory compliance training.

Some life science companies (e.g. pharmaceutical, medical device, laboratory, blood/tissue, etc.) choose to manage regulatory compliance training by employing agencies or by managing training processes in-house. Though both these methods of management are in many ways sufficient they tend to present some problems which--like most business problems--are directly related to the always important bottom line.

The Agency Method
Take for instance the agency method. This method is practical in the sense that many agencies KNOW EXACTLY what they are doing. They’ve paved the road, planted the road signs and yes, they are asking for tolls—expensive tolls. Not only are their tolls often expensive but they are also iterative which equates to large training budgets that must be utilized annually, every 6 months or even more frequently. For some life science companies agencies seem to be the only option, but these companies could be reaping the benefits of a more effective solution.

The In-House Method
For other companies in-house training is all the rage. Training managed from within a company usually has the purpose of spending less essential revenue. However, many of the implemented in-house methods for regulatory compliance training management potentially present even weightier financial burdens than agency methods because training management personnel waste time keeping track (manually) of dozens or even hundreds of employees. For example, the training manager has to know whether Jane and Ben have completed their quarterly training, their annual training and their “unexpected” SOP training while simultaneously managing and maintaining all training records. Multiply this process by 100 employees+ and it’s easy to imagine the amount of pain killer required to douse this training headache!

Don’t forget however that wasted hours are funneled in other directions as well. The infamous paper problem is a prime example. For instance, many employees manage training related forms and documentation (tasks, follow-ups, SOP changes, quality manuals, exams, etc.) with hard copy paper and the costs and the hassles inevitably build up fast. Not only are hard copy records difficult to locate, track and file, they also take up valuable storage space and are likely—via pure frustration—to lower employee morale.

For some companies, in-house regulatory compliance training seems like the only solution, but these companies could also reap the benefits of a better solution.

A Combined Solution with a Twist of Technology
The best characteristics of the systems for regulatory compliance training (and other types of training) mentioned above can be combined with technology for a more efficient--and in the long run--less costly solution. The positive characteristics of the agency method for example is knowledge availability and the positive characteristic of the in-house method is the goal rooted in economic success. These characteristics, when combined with the appropriate technology can help create a recipe for regulatory compliance training success.

A Recipe for Regulatory Compliance Training Success

1) First, the knowledge of regulatory compliance training is essential. Without know-how, training is futile. However, agencies are too expensive with their iterative costs so why not set aside funds for an in-house training manager who has a knowledge (or a potential to gain that knowledge) of regulatory compliance training requirements and a knack for managerial success.

2) Though this in-house training manager will have the knowledge, he or she won’t necessarily know how to “spread it around” without spending large dollar amounts. He or she needs to focus on low expenditures. This is where the right technology can begin to streamline electronic regulatory compliance training processes.

3) Last but not least the right technology must be utilized to streamline the training process so the training manager can focus on the training information instead of the tedious training tasks and procedures. To do this, companies should search for a reasonably priced solution to automate their overall training system.

For example, companies should search for a solution that can provide the following features and benefits:

• Automates the routing of information related to training;
• Automates the tracking of training information;
• Automates follow-ups;
• Automated notices for new training assignments;
• Automated completion notices delivered to trainees;
• New training assignments can be automatically triggered when essential SOPs, quality manuals, work instructions or additional company documents are edited or significantly altered;
• Provides reporting features;
• Provides analytics features;

Conclusion
For regulated life science companies, regulatory compliance training management is no simple undertaking. It can be significantly less troublesome however with knowledge, an eye on a company’s bottom line and a reasonably priced web-based solution.