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.

Fairytale from the Future: Facial Recognition

For most organizations, the ‘new normal’ is synonymous to ‘remote working.’ Remote working also means remote learning and upskilling being the need of the hour, learning is a vigorous process with us all. But what happens to assessment? Remote assessment is not something we are used to yet. Though there are some instances of remote assessment practices, but they are not fool proof thus not good enough for desperate time like these.

Traditionally, the authentication of the person appearing for the remote assessment was being done through designated username and password, and also two-factor authentication but there’s a loophole. It does not have proof of authentication. Thus, to ensure secured proctoring of these assessments, GCube proposes Facial Recognition, and we implore you that you hear us out as we shall be surely answering all the questions of high cost and accuracy issue.  

As a client posed the problem, we got into action to research the challenge and that is how we arrived at the facial recognition solution to make proctored assessment process seamless and efficient with practically zero imprecision. However, like with technology, facial recognition has been presented with challenges in its capacity but, GCube’s LMS has countered and resolved most of the following challenges by integrating a robust system.

High costs involved in facial recognition: Facial recognition involves continuous clicking and matching of the images with the ones in the database. Every passing second involves 24 frames, so a session of 30 minutes will increase the cost manifold. GCube’s solution counters these exorbitant costs by clicking the pictures of the learner at irregular intervals (which cannot be predicted by the learner) and matching it with the database. In addition, the FR now is offered as a service by providers like AWS and Google Vision so there’s no need to build a separate infrastructure. This way the costs are greatly controlled without affecting training and assessment.

Improved accuracy: Another challenge that used to come in the way of using facial recognition is accuracy. As the current facial recognition systems are trained on larger data the accuracy levels have increased following the very basic principle of machine learning. Of course, add to this the availability of high-end camera equipment at reasonable pricing which has improved the FR technology by many folds.

Privacy – the bone of contention in the field of FR:  For a long time, facial recognition has dealt with the issue of privacy. This has however been solved in the GCube facial recognition suite by matching with the reference image and erasing the rest of the captured data except in case of a discrepancy. In case of any discrepancy below the mismatch threshold of 70% between the uploaded photograph and the snapshot, the following error messages, dependent on the upload will be registered:

·             MF – Multiple Faces Detected

·             OF – One Face Detected

·             NF – No Face Detected

The snapshots which do not cross the mismatch threshold are stored for the proctor or mentor for their approval along with the original photographs the learners have uploaded. The proctor or the mentor can then access the report workflow and deal with them accordingly.

Thus, we have now made Facial Recognition an accessible technology and not a fairytale from the future.  

With over 100 industry awards in learning technologies, G-Cube would love to share more information with you about our facial recognition solution engineered specifically for the learning industry. Please do write to us here.

GCube’s BFSI LMS: Must have Mobile-First Features

 

According to a study by Mordor Intelligence, ‘The mobile learning market is expected to register a CAGR of 21.45% over the forecast period 2021-2026.’ With the pandemic moving people out of office, this was inevitable but our experience with some of the largest BFSI organizations in Asia Pacific, helped us realize this sooner. Not showing-off but we already did build a Mobile-first LMS for our clients long back.

While one of our clients needed a mobile-first LMS to enable faster onboarding of its 40,000 strong sales team; another banked on this technology to help in virtual sales. It is not just them but organizations that rely on mobile learning solutions saw a 16% boost in productivity and improvements in creativity and loyalty of their employees.

With reports of the global mobile workforce being set to increase to 1.87 billion people or 42.5% of the global workforce in 2022, up from 38.8% in 2016, workers have become increasingly mobile, which includes their primary work device. Now, it is important to understand that building a mobile version of a learning management system is not just changing the UI. It requires well-researched and thoughtfully applied features to ensure security and connectivity.

Here’s how we did it.   

Sensitive Content Security   

Mobile devices are personal devices with a public network connection. Thus, the content like internal data, processes, reports, fund values, customer information and even training manuals vulnerable to online abuse. To secure sensitive content on the device, the GCube BFSI LMS comes with Personal Information Encryption. Screenshot is disabled for all content.

Information Security Readiness

Security requirement in BFSI sector is much higher than in any other industry. So, the mobile LMS comes with multi-factor authorization for log-in. We also integrate with Mobile Device Management suites that secures your mobile LMS app for distribution withing your authorized employee base. This protects your app from external abuse or malicious activities. Additionally, it provides a mechanism of privacy for anybody who are accessing sensitive content on the app.

Customer Service & Sales Enablement

A very large section of the customer service and sales workforce in the BFSI sector is dispersed and works on the move. To enable them the Mobile LMS comes with ready guides for Complex Products and SOPs. The BFSI LMS has a very specific suite to also enable virtual sales.

Adept to Lesser Infrastructure

The dispersed workforce in the BFSI sector poses yet another challenge for technology access and that is lack of standard infrastructure. While in some cases the issue is of lower connectivity and in some other case, it’s a less sophisticated device. The LMS has been built to be conducive to these devices and makes content available in secure, downloadable format to tackle network problems.

For monitoring this dispersed and mobile workforce, we are developing a fleet management feature as well with geo-tracking and geo-fencing solutions.

With mobility and security at the heart of our R&D philosophy, GCube has won more than 100 awards for the learning technology innovations made over the last 20+ years. To know more about our solutions, please write to us.

Intuitive LMS Design, Easy Navigation, and Seamless User Experience

Key Features that Remain a Priority for Corporate E-learning Platforms

In today’s digital age, technology is paving its way for learning to occur anytime, anywhere, and on any mobile device. As the scope of corporate training is evolving, and interactive LMS design and personalized user experience (UX) are no more merely ‘nice-to-have’ features of enterprise learning management platforms. Effective corporate learning strategies need innovative solutions that go beyond the functionalities of traditional tools. A robust training platform empowers L&D teams to boost workforce engagement and productivity, and a vital pillar of this solution is the enterprise LMS.

Why do Good LMS Design and Personalized Experience Matter?

Corporate LMSs support formal, informal, and social learning tailored to the needs of the globally spread workforce. These align learning to pertinent training goals that include compliance, onboarding, sales enablement, and more. Measuring training success depends on how well users navigate through the LMS portal, engage, and perform. The LMS UI signifies how well learners interact with the system by clicking on icons, menus, buttons, and other interactivities. Therefore, e-learning platforms need to be accessible, intuitive, and straightforward. The intuitiveness of LMS design and aesthetics leads to better UI.

• For instance, if the Like button looks like the one on Facebook, then users would be familiar with the functionality of the button.

• Similarly, an interactive UI enables learners to easily navigate between pages, thereby making the learner-system interaction simpler and more convenient.

• Also, the attractive design, themes, and graphics captivate the user's interest.

• Another crucial aspect of modern LMS is its responsive design. Consequently, users can access different e-learning courses on their personalized mobile devices such as smartphones and tablets. The mobile screens include scrolling, clicking, intuitive search, and expandable sections to ensure easy navigation and flawless user experience.

Today, factors such as attractive LMS design and exceptional UX are considered as the top priorities for organizations before deciding on what to implement. A bad UX also results in reduced engagement, which can be daunting to turn around. Choosing a robust LMS portal with a good UI/UX ensures that learners come back and use the system time and again. Visual appeal and information availability signify better UI, while the call to action such as clicking on an icon leads to a better UX. With technological advancements, online LMSs are shifting focus towards delivery technology-aided solutions such as microlearning, gamified learning, video-based learning, assessments, so on. These features help modern corporates to boost workforce performance, knowledge retention, bridge skills-gaps, increase ROIs, and drive overall growth.

Learning Management System Tools

Exploring the Topmost Learning Management System Tools

In today's fast-paced world, many organizations are leveraging the benefits of learning management systems to deliver engaging training experience. From serving as an online training platform to provide online courses to tracking learners' performance and delivering content on any mobile device, there are enormous benefits of using modern learning management system.

LMS Tools to Create Highly Effective and Engaging Online Courses

The intuitive LMS design also embeds different kinds of authoring tools to offer a personalized learning experience for globally dispersed audiences. Different types of learning management system tools are used to develop custom content, while PowerPoint based tools are used to host conferences and corporate meetings via the LMS.

The learning management system tools ensure to meet the personalized training needs of globally dispersed audiences and deliver a highly engaging learning experience. Let us discuss the top five eLearning authoring tools which can be used by organizations to stay ahead of the curve:

• Elucidat

It is an ideal elearning authoring tool to create custom training content for the LMS. Elucidat uses a pre-built template library to deliver an interactive experience for all. It supports a variety of options to customize training content as per the diverse learning styles, business needs, as well as review courses for all screen sizes. It enables the users to include interactivities by dragging and dropping text and media components to ecourses.

• Composica

A highly responsive and collaborative e learning authoring tool which helps to design eLearning courses, interactive games, and short quizzes using the browser. Composica also supports collaboration feature to allow users to interact with each other, share new ideas, and repurpose existing content. The robust SCORM compliant authoring tool gives the freedom to users to change the look and feel of the course as per their personalized learning styles and preferences.

• Office Mix

The LMS supports interactive content delivery by creating and sharing engaging presentations with the users. Office Mix also helps to embed voice recordings, polls, and simulations which can be viewed and accessed anytime through the LMS. It aids to control content accessibility, analyze how much time learners spend on each slide, and examine their overall progress.

• Articulate 

It is one of the most popular authoring tools which is used to develop training content for LMS portals. Articulate also supports a gamut of interactive and collaborative features to effectively create content, thereby driving optimal learner engagement and knowledge retention.

Technology is ever-evolving, so by investing your time and money in the latest learning management system tools, you can get the maximum out of the modern LMS to stay ahead of the curve.