Effective training management software plays a vital role in heavily regulated pharmaceutical environment. The three most found reasons behind GMP deviations are lack of GMP training, lack of GMP training and lack of GMP training.
The objective behind implementing current good manufacturing practices (CGMP) is to keep the organization compliance against various regulatory and quality standards, which you cannot achieve without providing constant training to your employees. Success in the area of quality and compliance can only be achieved when a multitude of variables are controlled and continually maintained from document control to CAPA control, and from audit to CRO management. An effective training management software is the key to get success in all the areas.
During inspection, one of the most important area where inspector will focus is your training management system, which ensure that your employees are aptly performing their assigned tasks. Training does not mean induction program only, it includes tailor made complete training planning for a year for each employee.
Excel spread sheets can be the solution but if you are operating globally then it’s not a feasible option due to following reasons:
• Error prone and time taking
• Lack of transparency and control
• Inability to establish effective communication
• Inability to produce as you wish reports
• Incapable to integrate with legacy ERP solutions
• Tough to establish accountability
• Tough to training set up, scheduling and intimating
• Arising noncompliance during internal audit
Hence companywide training management software is needed to manage the training needs in a pharmaceutical company. Smart training management software will reduce time and effort needed for planning, execution and evaluation of your training program. In general managing the complete GMP training cycle, starting with creating small groups of employees based on their operational and functional areas for micro level understanding of the pain areas, designing annual staff training plan specific for each group or each employee, executing the training program and then evaluation through documentation. Here in this article we are trying to showcase few of the salient features, smart traing management software should have:
• Ability to group employees based on their functional and operational role
• Should be connected with DMS so that whenever any SOP has been updated or new document version is available for specific department, should alert the training manager to plan for specific training
• Employees will sometimes assume new responsibilities and training for such employees must be adapted accordingly and if his old specific job profile assigned to another staff member then system will automatically flag the training requirement
• When an employee leaves the organization, he/she should be automatically removed from all profiles and all planned training sessions to avoid confusion
• Key performance indicators (KPIs) to calculate the ratio between the total number of trainings planned/needed, and the total trainings conducted, which helped management to assess and assign the necessary resources
• Ability to integrate with third party systems
• Should be 21 CFR part 11 compliant
These are the most required capabilities an effective training management software should have.