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. 

Using Corporate LMS Software to Train BFSI Workforce

The changing customer needs, industry regulations, and market dynamics have made the Banking and Finance industry to utilize corporate LMS software to improve training efficacy, revenues, customer experience, and ensure consistent training quality across all geographies. In response to COVID-19 disruption, the BFSI industry is adopting effective measures to curb its impact and emerge stronger than ever. Banks and other financial institutions are focusing on offering vital services, without affecting the customer experience and employee morale. Corporate LMS serves as a viable solution to meet diverse organizational objectives such as tracking employee performance, encouraging team collaboration, and driving overall sales. Consequently, this will bring a new wave in the industry by leveraging robust online training platforms to enhance customer services, increase ROIs, and stay ahead of the curve.

Amid the global pandemic, companies in the BFSI sector face a gamut of challenges associated with changing customers’ needs and regulatory risks. The operational challenges faced by the customers and remote workforce showed upa gap in the systems during the crisis.  Few challenges for the BFSI industry during the outbreak include-

• Most employees are working remotely and need to be well-equipped with the latest technologies to manage contactless payment, virtual meeting tools, how to effectively interact with customers, and more.
• With changing economy, remote employees also need to adhere to the changing regulatory compliances. So, banks and other financial services are adapting an agile methodology for an increased customer engagement and business ROI.
• Financial regulators are concerned whether the organizations adhere to the regulatory standards, and risk management is compelling enough.

 

The increased shift to digital learning has enabled banks and finance institutions to train their remote staff on critical processes adequately. Several benefits of corporate LMS software for the BFSI sector include-

• Collaborative Learning

The robust training management software supports social collaboration, enabling remote personnel to engage with the irpeers via virtual meetings. Corporate leaders can also actas mentors to educate their teams about the changing business strategies and workforce decisions. Remote employees can post their queries on online forums or virtually discuss through web conference rooms to share new ideas, individual experiences, and thus remain connected.

• Automated compliance

Banks, financial corporations, and investment funds need to train their remote staff on the mandatory compliances. In the current crisis, online LMS software serves as a viable platform to deliver automated compliance training, improving the company’s brand image amongst the clients and employees. The geographically spread workforce also needs to understand the changing work ethics, risk management strategies, andmandatory compliances. Ultimately, compliance training enables the workforce to understand financial regulations, improve career paths with knowledge retention, and prepare better for the future.

• Employee Upskilling

The wave of digital transformation is rolling across every financial institution and bank. It has become vital for the industry to upskill its remote employee and boost their morale. So,managers should utilize corporate LMS software to become a mentor for employees in developing soft skills such as resilience and stress management to cope with the current situation. They should also teach the top talents about leadership and project management skills. Consequently, the LMS provides room for employees to engage, retain, and upskill, thus helping the organization to grow and succeed.

Amid the global crisis, the BFSI industry is at the cusp of sheer evolution in regulations, policies, and overall culture. Therefore, it becomes vital to deploy the robust corporate LMS software to engage, retain, and upskill the remote workforce.

GCube is one of the fastest growing organizations in Asia Pacific offering complete learning technology solutions for diverse verticals including automobile, BFSI, healthcare, aviation, and others. With over 80+ industry awards, our solutions range from enterprise LMS, custom content development, Virtual Instructor-led Training solutions, mobile learning, micro learning, translation and localization in over 60 languages. To know more, you can write us at info@gc-solutions.net.