Qualities of training management system for Pharmaceutical industry.

The Pharmaceutical industry is one of the most regulated industry need to adhere the stringent guidelines of various regulatory authorities like FDA, USFDA, MHRA, TGA and many more. Because Pharma industry is directly connected with the wellbeing of human health. These stringent guidelines are good from customer’s point of view but it’s a challenge for the industry players to achieve smooth compliance. Let us see the features of training management system.

The common weakest area identified during the FDA audit is ineffective training management system. Keeping the employees aware about the good automated manufacturing practices is both time and cost consuming. According to the recent research US pharmaceutical industry spends over $ 1 billion dollars in training. Of the billion dollars, over $ 150 million is spent on the training content and rest is the travelling cost of employees attending training session.

Another study revealed that, a staggering 51% of employees in the Biotech and Pharma industries are reported to be likely to seek out new employment within the next six months. One of the biggest reason behind this is lack of training and scope of career advancement. In this blog, we will discuss about the qualities  of training management system for the Pharmaceutical industry, from the employees and business point of view.

 Qualities of a modern training management system

• The types of training required for employees to work in the Pharmaceutical industry complying with the industry guidelines include environmental training, Standard Operating Procedure (SOP) training, Current Good Manufacturing Practices (CGMP) training, etc.

• Training management system for Pharmaceutical industry should also be compliant with protocols such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Any training management system implemented should be compliant with the FDA guidelines on electronic records and electronic signatures in the United States – Title 21 CFR Part 11 of the Code of Federal Regulations.

• Regulations are continuously evolving due to rapid changes in the industry which means that employee training is an ongoing process. The training management system used to impart the training should have the ability to adapt and scale effortlessly to keep up with the changing demands for training.

• Due to extensive auditing requirements to fulfill compliance, training management system reporting on employee training should be extensive.

• Ability to access courses on the go using any device on any platform, with particular focus on mobile devices.

As discussed, training management system should have all the above mentioned qualities, mostly in connection with the complex regulations the industry has to adhere to. It becomes prudent for companies to do extensive research before choosing the right training management system for their requirements.