The pharmaceutical industry is one of the industry needs to operate under the shrewd scanner of various regulatory and quality authorities. Every year Pharmaceutical industry waste billions of dollars as a fine against the warning letter, include list of all non-compliance issues detected issued by FDA. The organizations in this industry bound to provide quality product to enhance the safety, efficacy and security of human health while meeting compliance requirements. According to CIA’s (Corporate integrity agreements’) organizations must work towards continuous improvement and without comprehensive training management system it’s not achievable.
Before delve into much deeper let’s understand what CIA (Corporate integrity agreements’) is?
The Corporate Integrity Agreement (CIA) is an enforcement tool used by the Office of the Inspector General (OIG) within the Department of Health and Human Services (HHS), to improve the quality of health care and to promote compliance to health care regulations.
According to CIA every organization needs to allocate specific no. of hours for training annually. Organizations must include comprehensive training program as a part of good manufacturing practices (GMP) but with an age old manual methods you cannot attain your objectives. Let’s understand TLC (training life cycle) first.
Identify
Primarily organizations need to categorize employees as per their role and responsibility and then define training requirement for each category. This is very simple when think and said but it require lot of time for data mining and consultation with department heads. After all this if you managing these valuable information manually then there is always a fear of data security and errors.
Chalking a road map
Pharmaceutical companies need to develop training code of conduct, policies and yearly road map-all within a defined time frame by CIA. Manually execution of these activities consume much time, cost and effort.
Implementation
According to CIA every employee should complete 100 % of their training program which is very tough when you are managing this manually. Scheduling training after checking availability of participants and trainer, inform the participants regarding training, setting reminders are the cumbersome task when managed manually.
Tracking
Organizations have to keep track of training and employee attendance which is a difficult and time and space consuming job for administrators if they are using manual methods. Manual methods are always error prone with lack of transparency and control.
Dynamic training management system is the perfect remedy for these pain areas associated with manmade system.