Case Study on GMP Learning Management System
How AmpleLogic– Learning Management System (LMS) ensures one of its client to have a competent and compliant workforce
Client Snapshot: One of the largest and fastest-growing pharmaceutical company in India, has its headquarters in Mumbai wanted a Learning Management System. The platform should be accessible anytime, anywhere, would be ideal for the employee training needs of the organization
With over 5000+ plus employees our client has very rapidly become one of the fastest expanding pharmaceutical company. It is approved by many stringent regulatory bodies across the world like USFDA, WHO, MHRA, and European Union etc. So there are strictly following Common Good Manufacturing Practices (cGMP and GMP defined by FDA (Food Drug Administration).
Business Challenges – Training System
With over 5000+ employees and an employee turnover percentage that ranges from 25%-50% managing training and compliance requirements was a big challenge. Due to a large number of employees, worksites, and departments in the company they relied on onsite or in-person training driven by the team members.
There was a lot of inconsistency in the content material and quality of training provided. It’s also difficult in a company of this size to track whether training was done correctly as per the requirements to produce superior quality of products.
Like many others, our client used Microsoft tools like spreadsheets, Word (Paper-based methods for managing training management needs. They delivered over 1,000 plus instructor-led classes in a year and had no centralized system for managing all sign-ups and attendance of the employees
So our client used to face many business challenges like:
- Using Paper-based training materials which had to be purchased by suppliers and delivered to the respective locations.
- Creating high-quality training materials or manuals are printed in bulk, it made difficult and too expensive to update the training material on a regular interval of time
- Whenever there are changes in policies and procedures, all these updates are done on paper and so it takes time to distribute materials to all locations, regions and obtaining each employee signatures
- Employees could not be notified of training requirements so admins had to individually email every employee when training was required
- End users had to manually print course completion certificates, documentations and administrators had to request copies in order to keep records for audit purposes
- Cannot assure 100 % accuracy that all the employees or staff members across the locations are trained properly on compliance requirements, safety training specific training per job description and responsibility
Solution Approach – Learning Management System
Our domain expert team deeply their pain areas across the multiple departments of an organization and so our client decided to adopt AmpleLogic – Training Management Software to replace their outdated paper-based system with a way to securely distribute materials that required an employee signature as well as deliver consistent training.
AmpleLogic – Learning Management System is an intuitive solution which offers them a centralized platform where they can streamline, integrate and smooth training practices. AmpleLogic web-based learning management system is web-based solution ensures quality and regulatory compliance and allows our client to keep electronic training records, employee records like their Job Description, CV, and Role Change, etc. in a secure and easily retrievable way. It defines the key responsibility area for each employee, identify training needs, design training module, communicate about the training programme to the respective employee and upload training documents.
It also gives email alerts about the next required training session or any updations in existing SOP (Standard Operating Procedure) and works instructions policies or repeat training is required such as GxP training to the training managers
Business Outcome – Results with Training Management System
- Streamline entire training set up, assignments and scheduling
- Ensure regulatory compliance
- Attendance and signups of employees can be easily marked with the help of biometric after the training
- Gap Analysis report of completed and pending trainings for all trainees can be generated based on assigned trainings as per role, job descriptions, which also ease both internal and external audit process
- Assessments for courses can be conducted with the help of tests and quiz with randomized questions.
- Auto email notifications and reminders to trainees & trainers when new courses assign to trainees when changes in training materials
- Yearly training calendar helps users to plan training for the entire year on a weekly basis, monthly and schedule training accordingly
- Reducing the risk of incidents caused by untrained employees across the locations
- Grouping of employees based on Job Function, Position, and user-defined groups
- Capability to track compliance with state and other regulations on training and produce audit reports confirming employee compliance with applicable regulations.
- Easily integrates with ERP and other existing systems like QMS, DMS and HR modules and works with Bio-metric fingerprint technology.
- Generate user defined reports, metrics, certificates, assessment reports, performance reports etc.
- Reduce Training Cost and Operational Costs
- Create GMP & OJT yearly training planner and SOP and External Training Programs.
- Track all learning sessions, record, and histories of sessions