Making Pharma LMS GxP Compliant

 

A regular admission of our Pharma Solutions team is that they get requests from clients for an LMS which complies with GxP requirement. And it is interesting to see that even with such a large demand base, there are few products that are customized to their needs. While the need is such, traditionally the LMS and the DMS/QMS are maintained separately and the perennial client complain remains that this leads to higher overheads and vulnerabilities in compliance monitoring.

From our exploration as an LMS provider trying to figure out the optimal solution for GxP in training systems, the challenges identified were as follows:

• System maintenance, risk analysis and record keeping
• Regular system checks and a plan for business continuity
• Information security guidelines being followed based on rules of the country of operation
  
  

Based on the same we have a list of recommendations for your Pharma LMS to ensure long term GxP compliance.

System Qualification for IQ, OQ and PQ validation

For a manufacturing unit to claim to be compliant to GxP, one has to have the information of IQ, OQ and PQ and the concurrent validation available for the LMS. and creating a system qualification of the software becomes an important step to ensuring future GxP compliance.

Service Patch Records and Risk Analysis

Like any software, your LMS has to be updated regularly. However, to remain compliant, it is important that records of all service patches and risk mitigation steps are recorded on the LMS to show to Auditors that all possible steps have been taken to avoid major incidents.

System Checks and Business Continuity Planning

The LMS should come with a process for regular checking of the system. It is also required to have alternate documentation available in case of a single point or multiple point failure of BCP.  It is always advisable to store SOP and Quality guidelines in a backed-up server or the Cloud to remove on-premise vulnerabilities to knowledge or break in process. This storage also needs to come with the highest levels of security but should be accessible so work can continue at other facilities in case of one facility being affected by any major incident whether man-made or a natural disaster. There are many different options to select from including but not limited to AWS and Azure. Auditors love a good Business Continuity Plan that is secure and scalable.

Information Security Guidelines

The regulatory bodies are very particular about Pharma companies demonstrating that the InfoSec guidelines related to the country or region. While choosing an LMS it is important to acquire one that has ready documentation available to avoid any kind of non-compliance incidents been reported during a GxP audit.

While these are standard procedures required for the pharma industry, clients face major time loss trying to get these customizations done to their LMS. We suggest being proactive while looking for an LMS, rather than reacting after getting one.   

At GCube, we have 20 years of experience and 80+ industry awards in learning technologies. To know more about products and services, please do write to us. 

Reducing of Time to Productivity

 

Large product portfolios with varying level of complexities for new teams with different levels of skills and knowledge. Have we been able to state the most basic issue of your life as BFSI leader? Our gut feeling is that we have. Longer time to productivity usually always means lesser time at peak productivity due to compliance mandates and certifications in your industry.

Thus, the basic and foremost requirement of any BFSI organization is to achieve shorter TTP and here are 5 steps to do the same. All you need is the right LMS.

Step 1: Pre-joining Engagement

The idea is to identify the skills and abilities of each individual right at the time of joining so there is no wastage of time and effort. The information can be captured on the LMS which can then deploy trainings according to the levels at which the employee currently is. A pre-joining training kit which may contain information about the organization, leadership, payroll etc also helps the employees settle down faster with the company with a sense of belonging.

The pre-joining involvement through the LMS creates the opportunity to deploy all the basic training modules related to the company’s products and key phrases or industry jargon so that your new-hires can hit the floor running. Of course, these will be material which are available on the public domain and are not proprietary documents. 

Step 2: Creating Personalized Learning Path

With information gathered and basic training deployed in the previous step, an effective LMS can then assign automated training to a new hire to bring them at par with others in their batch or even move someone to advanced batches if they are ahead of the others. Keeping in mind the different skill levels, talents and learning styles, a good learning management system can create a learning path for individuals based on multiple factors and help them to find what they are good at and truly enjoy doing. This in-turn helps them achieve peak performance faster.

As the learning is mapped to the job role or product an individual is handling, the LMS can throw up timely notifications required for certification or guideline updates which otherwise leads to confusions and loss of productivity.

Step 3: Create Immersive Learning Experience

The number of products in BFSI is extensive and often riddled with complexities that employees must navigate and be able to explain in simple language. This means they require in-depth understanding of the product, which is easy to deliver through interactive media via an LMS. Trainees are offered life-like simulations for scenarios, understanding of product combinations and with inputs from sales teams for real questions asked by customers. What they get is an immersive experience and are more confident to achieve peak performance faster.

Small learning nuggets can be sent to the employees at regular intervals, automated through the LMS. This ensures continued and reinforced learning which reduces knowledge loss and creates better customer experience.

Step 4: Segregate Experience Employees from new ones

Segregation of training programs and content based on who the audience is effectively reduces time lost in futile training or retraining. An LMS is again key to this step to achieve desired results. For example, the same product needs to have two deliveries. For basic level folks who need more detailed explanations and an advanced level for whom it can be a quick upskill intervention. As your LMS already has the learning data of each individual, it can help you identify the right kind of training required for a particular individual who is at a particular level of understanding or experience.  

Step 5: Make Learning an Agile Process

A company that has a tradition of agility will always find it easier to handle bumps in the road. Like most things, training processes and systems also experience fatigue and become outdated very quickly. BFSI companies need to invest in an LMS that are built to handle and respond to update needs in an intelligent way. A good LMS will allow deployment of changes, alerts to roles who need to learn or get certified, and also give leadership visibility to the status of certifications, especially those that fall under the compliance umbrella.

Knowledge is very liquid and relative, especially as the typical time in a role gets impacted by attrition, role change or promotions. Leaders need to be able to get more time per resource at peak productivity and the right LMS can be an ideal partner to help organizations achieve their Time to Productivity goals.

At GCube, we have 20 years of experience and 80+ industry awards in learning technologies. To know more about products and services, please do write to us. 

Automotive Industry Update: Learning Management Systems Should Be Industry Focused

Hiring an electrician to do a plumber’s job, could lead to someone or something getting zapped. Similarly using a corporate learning management system (LMS) to deliver training to the personnel at your auto dealerships can bring about dissatisfactory results.

To understand the learning needs at an automotive dealership, we looked at the variables that make our auto industry clients’ dealerships unique.

1. Diverse and non-homogenous skills and education of the work force
2. Unrelated departmental goals at first glance
3. Skewed trainer to dealership ratio
4. Lack of structured training before shop floor exposure
5. Unavailability of logical linking of training and performance

Our study suggests that for automotive dealerships the choice of LMS needs to be industry specific in order to overcome these issues. The following key features are what sets the Auto specific LMS apart from the rest of the lot. Read on.

On the job training and evaluation

At most dealerships, a new hire goes from completing their joining formalities to the shop floor directly. Under these circumstances where there is no formal training, it is important to have an LMS which has inbuilt forms, checklists, and tools. This helps mentors or seniors to keep track of everything they need to share with a trainee, and to evaluate a trainee’s performance while on-the-job.

Predictive analysis of individual’s performance to annual sales trends

Almost every role, whether customer facing or not, has an impact on the brand and reputation of a dealership, which ultimately impacts the annual sales trends. Therefore, an LMS which connects trainings attended to performance in their job roles, and then extrapolates that to find trends impacting sales, gives the leadership a way to predict training needs.

Simple user interface for diverse workforce

There cannot be different learning management systems for different departments at a dealership. Therefore, the LMS of choice must have an interface that is easy to use by an undergraduate mechanic with 20 years of on-job experience with automobile engines. With smartphones and tablets, it has become extremely easy to get a knowledge device into the hands of the employees, but the delivery of knowledge must be easy to handle and understand.

Sales and service enablement tools

Customers want great service and at a price point that makes sense to them. Whether the customer is purchasing a new vehicle, exchanging an older model, or getting one serviced, the employees talking to the customers should have knowledge, expertise, and customer service skills. Some things can be imbibed through training, but some things like market prices, loan rates, parts availability, etc. needs a ready interface that provides this information to the employee. An LMS that gives the flexibility to set up chat-bots, comparison charts, and calculators to enable point-of-sale assist is a blessing.

Integration with management systems

Integration with the CRM or dealership management system allows the LMS to fetch performance data and link it to the trainings attended or available. This also creates a visual chart or dashboard to be available to view and manage the extended workforce.

Optimum training resource utilization

When the ratio of trainer and dealerships is not optimal, the trainer has to travel extensively. Having an LMS that can track trainer calendars for availability and scheduling, and other resources such as room availability really helps. The LMS should also have an OTP feature for when the trainer starts a training. It should be able to capture attendance via an app and should also be able to deliver proctored assessments. If the LMS can provide all these insights, then it becomes easy for leadership to track the cost-benefit ratio of this method of training delivery.

In an industry that is in a constant state of flux, being able to empower and enable all the personnel at a dealership to put their best foot forward is essential. The right learning management system can help provide stability to employees and prepare them for handling the changes the future may bring.

We at GCube, have 20 years of experience and 80+ industry awards in learning technologies; and would love to hear your thoughts, queries, and suggestions. Please do write to us.