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.

How does SCORM Compliant LMS Save Time and Mitigate Training Cost by 80%?

SCORM (Shareable Content Object Reference Model)- a global standard for online learning platforms. It serves as a platform that supports communication between online training content and learning management systems. New-age SCORM compliant LMS enables organizations to develop tailored e-learning content for laptops, smartphones, and tablets. It also supports easy uploading and updating of relevant training courses as per the pertinent needs of a globally dispersed workforce
Today, companies from diverse industries realize the potential of SCORM compliant LMS that caters to bespoke learning objectives. Several benefits of SCORM LMS include the following:

• As SCORM is the de facto e-learning standard, it enables the seamless delivery of training courses across multiple mobile devices (both Android and iOS).
• The global standard helps to create as well as repurpose existing content, thereby mitigating overall training costs by 80% and saving effort.
• Content created and delivered through SCORM LMS is adaptable. So, you can easily create and provide tailored content to employees working in-house or at remote locations. Consequently, this supports learning on the go by allowing employees to undergo training at their own pace of time and convenience.
• SCORM compliant LMS supports interoperability features between different software products. You can develop tailored e-learning courses using robust authoring tools, including Lectora, Captivate, Composica, and others.
• Modern LMSs that are SCORM compliant also support automated performance tracking and reporting features. The platform can easily track courses completed, time spent on each course, evaluate individual scores, test results, and so on.

Other benefits of corporate training platforms that are SCORM compliant include the following:

• Accessibility- SCORM content is packaged in a way that you can access relevant training material across smartphones and tablets, ensuring learning anytime, anywhere, and even on the go. SCORM content can be quickly delivered to various locations without any need for installation or reconfigurations.

• Adaptability- SCORM compliant training content perfectly fits the ever-evolving learning needs and performance goals. It is adaptable with multiple mobile devices and for different training groups with varied job roles and preferences.

• Reusability- To move away from classroom-based training, corporate trainers and managers develop SCORM content, which can be repurposed to cater to diversified needs. For instance, an automobile company wants to train its salesforce about the latest products and services. So, the trainer can create short video nuggets or podcasts, which are easier to access and quick to digest. The same content can be reused whenever there is any product launch or upgrade.

Overall, the above-discussed features help to improve employee engagement, bridge skills-gaps, boost workforce performance, and increase business revenues. With digitization, companies from varied industry verticals deploy SCORM compliant LMS to align the right kind of learning for targeted audiences. Modern learning management systems utilize authoring tools to create personalized training content for a globally dispersed workforce. Consequently, SCORM LMSs help to mitigate overall training cost, time, and effort, while allowing to create and reuse the same content within a few clicks. From pharmaceutical and automobile to retail, finance, and others, the implementation of SCORM LMS platforms is evolving at a fast pace. If you want to develop training content to track employee performance, reuse existing content, or want to integrate the system with other vendors, then SCORM LMS can serve as the best fit for your organization.