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.

Facial Recognition is not a Remote Assessment Fairytale Anymore!

Aviation is a dynamic industry and trust us, when we say that we understand the multi-layered issues of training and assessment in an industry where the workers are continuously on the move. In a set up that is so highly regularized and rightly so, training is not a casual upskilling exercise. The training in aviation is incomplete without the assessment and the authentication of the learner during this assessment which is remote in many occasions due to the dynamic nature of the industry.

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 the loophole remains that 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, the FR solution in GCube’s Aviation 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 Aviation industry. Please do write to us here.

Volvo Eicher’s Itube: User Generated Content for Training Revolution

Multi-media learning has been accepted to create better retention for a while now and L&D has seen the uptake of audio-visual learning for decades. However, the pandemic fast-forwarded our worlds and things changed rapidly.  According to Think with Google, 58% learners are using digital video to learn new skills in the post-pandemic world.

Given the blue-collared nature of work in the auto industry’s manufacturing units and service centers, watching and learning is an absolute necessity and thus the value in using video as a medium is clear. When Volvo Eicher approached GCube for a learning solution that will work for their dispersed workforce with variable educational background, we immediately identified the need for video-based learning. However, given the volume of content needed and variety of learners we were catering to there were two major challenges:  

• High costs of video production with proper content localization.
• Time taken to create the same.
  

Thus, ITube was built. ITube is a video sharing platform integrated in the GCube LMS for Volvo Eicher which is a channel-based video platform built exclusively for the client’s workforce much like the more commonly used counterpart, Youtube. The platform curates user generated content which are naturally localized, low cost and also come from in-house Subject Matter Experts.

 How did ITube solve the above stated challenges?

Leveraging localized and user generated video content: Itube resolves the time and cost issues by allowing their workers to create videos. Effectively deploying the user generated video content model for sharing knowledge. This not only brings down the cost but also crunches the hefty process of content generation from 15 – 20 days to just a 5-minute exercise. Suppose there is a need for short format videos on various parts of trucks. That will be a lot of videos with a very high production cost and also will need experts. But here, a senior worker can create a video on their respective work area and upload it for other juniors to learn from. The same can be done for topics related to features, offers, objection handling, addition or removal of parts, upgrades, after sales support and many other areas which become beneficial for the entire force.

Quality check through content moderation: Though Itube grants the content creation rights to all users, it gives singular authority to a moderator to ensure quality control measures remain in place. The moderator curates the user generated video content and after passing the quality check process they are uploaded to the video platform.

Concrete strength to the internal stakeholders for training:  Itube helps the internal leaders to increase their contribution to quality of training. Plus, it comes with a string of benefits like organizing contests for the HR teams from a content development standpoint. This adds strength to best practice sharing within the company.

Itube also comes with a live-broadcast-to-active-audience feature which increases engagement and retention.

How ITube created better learning strategy through videos?

1. With users generating video content, the first positive impact was on the number of knowledge videos spanning across a variety of categories, that were created every month. There are more than 350 videos on the platform with almost next to nothing development cost.
2. The basic fact that these videos were created by friends, colleagues, peers or seniors immediately raised the number of views, average duration of video consumption, and engagement levels of the knowledge content. As on 1st May 2021, the total users on the platform are close to 11,500.
3. Localization of video production provided a distinctive demographical edge as content was created from different regions, using different languages, and keeping in mind the preference, culture and sensibilities of the audience in that area.
4. This further allowed content distribution and penetration to the furthest corners of where Volvo Eicher ran operations.
5. By using the metrics from ITube rewards could be given to the best video content creators, providing gratification for their efforts and motivating others to get involved.
   
   

Itube is a revolutionary video training content platform that was specifically designed keeping in mind the unique characteristics of the automotive Industry. It has already delivered on its promise to Volvo Eicher with the total number of users of the platform going up to 7300.

With 100+ industry awards, and 45 new clients onboarded in the last financial year, we at GCube would love to share more about everything Itube can do for your company. Do write to us at info@gc-solutions.net.