Share on facebook Share on linkedin Share on twitter Onboard and Retain the Best Talent in the Pharma Industry with an Enterprise LMS

 

There is a lot of development in pharmaceutical research, manufacturing, storage, distribution, quality control, logistics, and sales. Every day, new drugs are introduced based on this research. Simultaneously, several drugs are discarded or banned based on the same findings. In parallel with this, there is also a lot of research and innovation in related technologies. Subsequently, new processes and policies are being put in place by organizations like the FDA. To cater to such a complex business environment, the Pharma Industry is constantly in need of highly skilled employees, and talented candidates are scarce, making hiring a complicated path for the Pharma business compared to most other industries.

 

To bridge the gap between required and available talent, the Pharma industry relies on corporate learning and development initiatives. The most important of these initiatives being the onboarding of the new hires.

 

Along with hiring, retaining talent is also a challenge. According to a survey done by BioSpace, 67% of biosciences employees were looking at changing their jobs in 2020. However, due to destabilized markets during the pandemic, people refrained from moving, but now the trend has returned with the post-pandemic growth spurt. The regulated nature of the industry makes employee churn an issue, and the BioSpace survey reports:

 

“In fact, at least one study indicates the cost of each employee’s turnover ranges from 70 to 300 percent of the annual salary of that employee. And the replacement costs are about 2.5 times the salary of the individual.”

 

To find the appropriate solution to these two talent-related issues, it is important to understand what motivates employees to join companies and stay with them. The Work Institute Retention Report 2020 states that the top three categories for leaving in 2019 were Career Development (19.6%), Work-Life Balance (12.4%), and Manager Behavior (11.8%). The same reasons featured in the article by job-search website, ‘Indeed’ in 2021. It is notable here that the Work Institute Retention Report 2020 also mentions that over one-third (37.9%) of interviewees exited their organization within 365 days or less. Two out of three employees who leave in the first year do so in the first six months.

 

Two of the reasons cited above, career development and manager behavior, account for 30% of the attrition. Also, the main reason for employees leaving the organization within 365 days or less can be linked to the initial 3 months’ experience of the employee when they are onboarding with the organization. We believe that most of these issues can be solved by effective training and development programs. In this article, we will examine the role of an enterprise LMS or Learning Management System in solving onboarding and retention problems.

 

Amit Tyagi, Customer Success Head at G-Cube shares: “The modern learning management suite is capable of doing a lot more than just manage learning. With the right insights, a corporate LMS can be easily used to train, engage and give a growth vision to your employees.”

 

 

 

Some Elements of the Enterprise LMS that helps onboarding and retention

 

 

Pre-Onboarding Engagement

 

Working remotely is the future, and it serves your purpose perfectly. With a cloud-based learning management system, you don’t need your new hire to come to the office to initiate them into the organization. With multiple formats of content support, the LMS can start engaging your new hire even before their onboarding process begins. LMS, as a repository of content, makes knowledge transfer easy and hassle-free. As such, it helps reduce the anxiety among the new joiners who can then access this information without waiting for a manager or HR.

 

 

Abundant Training and Timely Certification

 

Pharma has a complex knowledge requirement. Product, process, policies, compliance, risks, safety – managing the plethora of knowledge in an easy-to-access search is important to create a suitable learning environment for employees. A major cause of concern among new hires is the requirement of rigorous training and certification related to their job role. Having to manage that manually can result in various clerical errors, which can result in serious implications with auditory authorities. Having the training content available at their fingertips boosts the employees’ confidence, and the LMS automatically tracks the certification requirement and expiry, relieving them of the pressure of monitoring it manually.

 

 

Provide Growth Vision

 

Research suggests people are less likely to leave their jobs if they have a career development vision. Use your LMS to assess the current level of skill and expertise of your employees, gather inputs on their vision of their career, and offer training based on these attributes. This practice demonstrates that employers are taking their career development needs seriously. For new employees, engaging with senior management can be daunting. With the LMS helping them visualize their path and growth with constant support, employees feel comfortable and give their best.

 

 

Improve Employee Feedback

 

In any organization, feedback should be a two-way process and as Pharma comprises a highly skilled workforce, it is especially important that they feel heard. The enterprise LMS can help you gather feedback from individual employees on their experience with their peers and even managers without running from desk to desk.

 

 

Predict Employee Churn

 

Everything is based on how you read your data. An enterprise Learning Management System helps you track a multitude of data. By tracking scores from relevant workplace assessments and correlating them with employee longevity, employers can identify risk factors that require intervention to prevent employee churn.

 

 

Traditionally, a paper-driven process like onboarding has been treated mostly as a formality, but researchers have highlighted the impact it has on the new joiner and how important it is to give them an immersive experience in the first few months. G-Cube Learning Technologies unit has a dedicated customer success team who can help you envision all possible solutions to your business challenges through the right learning and learning-tech interventions.

How is GCube’s Pharma LMS 21 CFR Part 11 Compliant for Audit Trail Management?

Our clients in the USA, have complained of sleepless nights due to the fear of receiving FDA 483 letters. So, even before we start the conversation, we understand your pain. As many as 429 organizations have received warnings from the FDA for non-compliance related to creating or following SOPs and problems with record keeping. In our endeavor to build a pharmaceutical specific LMS, GCube has built a learning solution that not only manages your audit trails and learner records effectively but is also in compliance with 21CFRPart11 guidelines.

In our analysis of the problem of FDA fines pertaining to audit trail management that we were trying to solve for our pharma clients, the few major challenges that came up in our scrutiny were as follows.

Manual Management

The audit trails and learner records are usually maintained on excel which of course is does not suffice when the scale of the records that needs to be maintained grows. The traditional practice of paper-based record keeping is also discarded due to the inefficiency and manual errors that is kind of obvious. As this practice made audits a tedious process due to lack of data availability, the FDA mandated e-record keeping and e-signatures.

Secured System

In a real-life situation, a big Pharma company’s drug got cancelled because an official mistakenly put a backdated signature on a document. The lack of a secured system that does not allow any backdated activity and maintains a rigid audit trail for the authorities is a necessity to avoid any situation that may lead to a compliance failure.

Huge MIS

Auditing happens of not only procedures but for each job role related to the procedure, training, process documents, hardware and software, external agencies, changes, and modifications in the process. It is herculean a task, to even visualize the gigantic amount of data that has to be tracked and monitored to avoid issues with the authorities.

We have solved these challenges with customization of the GCube learning management system and here’s how.

•  The QMS and DMS are integrated with the LMS to create a single repository of processes, documents and training related to the same.
• All the records in the system are validated; no invalid record is stored in the data stores (Database, Files etc.) even temporarily. Any invalid input is rejected, and system asks user to re-enter the valid input.
• A combination of login code and password is used as e-signature at all the instances. To every record which is added to the system, the id of user who has added the record is maintained. This id is linked to the user account profile which contains its login code and digital signatures.
• Every change in the system – addition, modification or deletion of the entity is tracked in respective audit trail. These audits are non-modifiable and cannot be deleted, however can be archived by the authorized users.

• The records once added can be updated or deleted only by authorized users. No one else can access the record for any modification. The system also limits the access to feature(s) only to the valid users. Only the authorized users are to view screen and modify the authorized objects.
• An approval process is there before finalizing the learning objects, hence, maintains sanity of the data. For ready retrieval of data, there are multiple standard reports and custom reports.
  
  

With our 20+ years of industry experience, R&D at GCube is always client-centric and practical. With a host of industry specific customization, our Pharma LMS has helped multiple clients from the industry avoid multiple training challenges, including non-compliance.

To know more about our solutions, please write to us at info@gc-solutions.net.

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.