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.

Why do Organizations Need the Best Mobile LMS for Workforce Training?

With the advent of mobile devices such as smartphones and tablets, the scope for mobile Learning Management Systems is improving. So, owing to the mobile nature of the new-age workforce, it is essential to deploy the best mobile LMS for smartphones, laptops, and tablets. The robust mobile LMS platforms align training to varied job roles such as sales employees, pharmaceutical executives, and field workers.

Benefits of Mobile LMS

The mobile-first Learning Management Systems aid organizations to meet the diverse training objectives and performance goals. Significant benefits of mobile LMS include-

• Intuitive interface

Organizations deploy Learning Management System mobile apps that are simple to access and visually-appealing. If the screen is cluttered, then the learners may find the content boring and navigate somewhere else. So, it is essential to add clear instructions as to how to navigate through the system. An intuitively-designed mobile app and seamless navigation ensure better accessibility and easy adoption for an engaging experience.

• Continuous learning

Mobile LMS platforms also send timely updates and reminders to individuals. As a result, employees are aware of the upcoming training, overall progress, mandatory training, and others. As learning becomes more personalized and continuous, employees can effectively work on improving their skills, finish the courses assigned to them, and perform better.

• Offline access

Learners can download custom mobile apps for iPhone, iPad, as well as Android devices to access relevant training content, even offline. They can also launch the courses from the download list in the mobile app without any need for Internet access. Once the net connection is back, the system automatically syncs training updates.

• Comprehensive training tools

The best mobile LMS platforms offer comprehensive tools to deliver an enhanced learning experience. These tools support features such as online whiteboard access, multilingual interface, polls, and raise-hand to drive collaboration, In-built media player, and screen sharing option for improved accessibility.

• Better compliance

With a custom mobile LMS, employees can undergo mandatory compliance training at the point of need. For instance, an employee is performing a task and does not know how to proceed without breaking the regulations. He/she can log in to the LMS via their mobile device and watch a short demo video. Sales employees can also access Augmented Reality-based videos on their smartphones to seek updated product knowledge. Consequently, they can bridge skills-gaps, improve customer relations, boost performance, and drive overall sales.

In addition to the above, mobile LMS platforms also support features such as video conferencing, geolocation for attendance tracking, texting, and others. Features including bite-sized content delivery, rapid authoring, and gamification ensure a better learning experience for all. Organizations are investing in the best mobile LMS platforms to enable administrators, trainers, and learners to focus on the top priority content, anytime and anywhere. The custom mobile apps provide added functionality to meet the bespoke training goals of the globally dispersed audiences. Mobile LMSs deliver continuous training, measure results, and drive growth, thereby amplifying every step of your training program. 

Mobile LMS App to Best suit your Modern Learners

Mobile LMS app - M Learning is the way to go!

With development of learning management systems with mobile app, learning technologies have made use broadband internet and wireless technologies access learning as per the just-in-time needs of the learners. M Learning now means learning not just on one device but multiple devices that are interconnected. This helps learners to find the continuity and right context needed for seamless learning. Progress and assessments can also be mapped across these interconnected devices.  

Learning Management Systems are not a new phenomenon in the Corporate Learning and all the best ones now boast of an LMS app - built in for effective m learning. Gone are the days when e-learning would force learners to be confined to a computer. Mobile LMS apps make sure that learners can now access learning not just at a specific location but wherever and whenever they require. With development of learning management systems with mobile app, learning technologies have made use broadband internet and wireless technologies access learning as per the just-in-time needs of the learners. M Learning now means learning not just on one device but multiple devices that are interconnected. This helps learners to find the continuity and right context needed for seamless learning. Progress and assessments can also be mapped across these interconnected devices.  

Why bother with M Learning? Because it makes sense! 

LMS apps deliver M learning that increase accessibility of learning as well increase the scope to include social and collaborative learning. The best mobile LMSs also include and support game-based learning to increase learner engagement. Game-based learning strategy has been immensely successful in creating impactful learning opportunities for employees. LMS app now have learning games and gamified learning content available that makes sure that boredom never strikes and halts the process of learning in the modern workplace. 

1. Learning Games on Mobile LMS app

For the benefit of the corporate learning, learning games must strike the balance between engagement and learning. Though learners love to engage with learning games, acquiring new skills or knowledge is a priority for them as well.  Learning games on mobile LMS can be utilized in many ways - imparting new skills, enhance knowledge, provide opportunities for practice and provide feedback on performance as well. This checks all the boxes in the list of expectations that most corporate learners have from workplace learning opportunities. 

2. Online or Offline Learning

The biggest benefit of m learning with LMS app is that it provides learning opportunities anywhere and anytime. This benefit is enhanced further for learning games as most learners are willing to try out the game even in their free time, making use of non-productive times like travelling or waiting between jobs and so on. Learning management system with mobile app provides an opportunity to learn even when there is no internet availability. 

3. Learning with Collaboration

M learning app is a powerful way of social and collaborative learning as well. Learners can connect with the LMS app with other learners through the social networking sites or even m learning games. Learner can post and share their scores or achievements on a ‘leaders’ board’ or tips on a discussion board. New learners can ask for help and get it from achievers who have been performing exceptionally. Collaborative tools built within the LMS app can support a comments section that can be the collaborative ground for discussions and learning. 

4. Engaging content with Mobile LMS app

The best mobile LMS help creating content with the help of audio or video recording. The use of mobile devices is very useful when providing the ready opportunity for learners to record on their mobile devices and share with other learners. Since most mobile devices have in-built hardware as well as software for recording as well as sharing, it is easy for learners to create learning content based on their experiences. 

With m learning and mobile LMS app, the learning experience of modern workplace learners can be enhanced. G-Cube LMS has a mobile LMS app which provides a highly personalized learning experience with custom Learner, Manager and Trainer features. In conclusion, Adopting a modern mobile LMS app is the modern way for learning and achieving the ROI of training.