In highly regulated industries such as pharmaceuticals, medical devices, and biotech; training records and learning systems are more than just business tools — they are part of an organization’s compliance infrastructure. For companies subject to FDA regulations, ensuring that training platforms meet 21 CFR Part 11 requirements isn’t optional — it’s mission-critical.
Recently, our team, working with Cloudrise Inc and IvyRock LLC, successfully completed the process of validating our SaaS Learning Management System, Coursabi, to be compliant with 21 CFR Part 11. It was a journey that combined technical diligence, regulatory understanding, and close collaboration with quality experts. Here’s how we did it — and what we learned along the way.
21 CFR Part 11 is the FDA regulation that sets the standard for electronic records and electronic signatures. It ensures that electronic systems used in regulated environments are trustworthy, reliable, and equivalent to paper records.
For a learning management system, this means:
Secure access controls
Audit trails for all training and record changes
Electronic signature validation
Data integrity and backup safeguards
System validation to prove it works as intended
Without compliance, training records in such industries could be deemed invalid — a risk no regulated company can afford.
Our first step was to thoroughly understand what 21 CFR Part 11 compliance meant for our LMS. While our platform already had robust security and reporting features, the regulation required specific documented controls and formal validation evidence.
We worked closely with compliance consultants and industry experts to translate the regulation’s language into actionable technical and procedural requirements.
Working with Cloudrise, we followed the standard validation methodology:
Master Validation Plan (MVP):
User Requirements Specification (URS):
System Configuration Specification (SCS)
Installation Qualification (IQ): Verified that the LMS was installed correctly in our SaaS environment, with all necessary dependencies and security configurations in place.
Operational Qualification (OQ): Tested each functional requirement — from login authentication to audit trail accuracy — against the regulation’s criteria.
Performance Qualification (PQ): Confirmed that the LMS performed consistently in real-world use cases over time.
Every test step was scripted, executed, and documented with results, screenshots, and approvals.
21 CFR Part 11 compliance isn’t just about software — it’s about how the system is used, updated and managed. We worked primarily with IvyRock LLC, to update several of our Standard Operating Procedures (SOPs) for:
HR-Employee Training Policy and Log
HR-Electronic Signatures Policy (submission letter FDA indicating our acceptance)
Q-Policy Format and Preparation Maintenance and Control of Polices
Q-Good Documentation Practices Policy
Q-Document Control Policy
Q-Change Control Policy
Q-Deviations Policy
Q-CAPAs Policy
SW-Version Control Policy
SW-Software Release Policy
SW-Computer System Validation Policy
SW-Coursabi Mission Control Administration Policy
SW-Coursabi Use and Operation Policy
S-Business Continuity Plan/Policy (specific to Coursabi)
These SOPs ensure that compliance is maintained long after the validation project is complete.
Our final deliverable was a Validation Summary Report, which tied together:
The validation plan
Test results
Deviations and resolutions
Final compliance statement
With this report approved, we could officially state that our LMS is validated and 21 CFR Part 11 compliant.
Validation is a team effort — involving developers, quality experts, and end-users.
Documentation is as important as the software itself — if it’s not documented, it didn’t happen.
Compliance is ongoing — system updates, infrastructure changes, and new features require periodic re-validation.
For organizations in regulated industries, using our LMS means they can:
Confidently train employees in a compliant environment
Pass FDA audits with complete, trustworthy training records
Save time and resources by leveraging a validated SaaS solution instead of building one from scratch
Working through the 21 CFR Part 11 validation process for our SaaS LMS was a challenging but rewarding experience. It pushed us to elevate our technical controls, strengthen our documentation, and embed compliance into the very DNA of our platform.
Now, our customers in regulated industries can focus on what matters most — delivering high-quality products and services — knowing their training system meets the highest compliance standards.
There's usually more to the story so if you have questions or comments about this post let us know!
Do you need a new software development partner for an upcoming project? We would love to work with you! From websites and mobile apps to cloud services and custom software, we can help!
Alkermes is leveraging their long-standing neuroscience expertise to develop medicines that make a difference.
During the COVID pandemic, Fynydd partnered with Blue Sequoyah Technologies (https://bluesequoyah.com) to build Coursabi: a cutting edge learning platform (https://coursabi.com). It's an all-in-one learning solution with features like native and SCORM course support, video conferencing, audio and video libraries, forms, reports, events, and more, all presented as a concise learning journey.
We found particular success in the pharmaceutical and healthcare space, and are proud to see these clients renewing each year as they find success in keeping their teams trained, compliant, and most of all, happy.
Alkermes (https://alkermes.com) has been applying deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. They're one of our first subscribers and we're proud to say that they have renewed their Coursabi subscription for 2025!
There's usually more to the story so if you have questions or comments about this post let us know!
Do you need a new software development partner for an upcoming project? We would love to work with you! From websites and mobile apps to cloud services and custom software, we can help!
Tools like Google NotebookLM and custom generative AI services are fundamentally changing how users interact with information. We're seeing a transition from static reports and interfaces to dynamic chat-based tools that give users exactly what they need, and even things they didn't know they needed.
If you're not familiar with NotebookLM, it's a tool that allows you to provide your own documents (like PDF, text files, audio), and then chat with the data. You can even listen to an AI-generated podcast that explains all the information. For example, I had loaded a project with PDF documents containing the rule book, technical rules, and officials briefing information for USA Swimming, and was then able to get answers to questions like "how is a breaststroke turn judged?"
It was kinda magical.
We've been working with clients on permutations of this scenario for some time. For example, we partnered with a client in the life sciences space to build a chat-based tool that connects various third party API services with disparate information, providing account managers with a single source for helping their customers recommend products and services to ensure better health outcomes.
This is no small feat when the goal is a best-of-breed user experience (UX) like ChatGPT. It can involve multiple service providers like Microsoft Azure and Amazon Web Services, as well as various tools like cloud-based large language models (LLM), vector search, speech services, cloud storage, charting tools, location services, AI telemetry, and more. But when it's done right, the result is amazing. You can ask questions that span disciplines and contexts and see results you may not have ever seen before.
Most organizations can really benefit from exploring how generative AI can positively impact their offerings and give them a competitive advantage. Like we always say, it's not about the organizations that use AI, it's about the ones that don't.
There's usually more to the story so if you have questions or comments about this post let us know!
Do you need a new software development partner for an upcoming project? We would love to work with you! From websites and mobile apps to cloud services and custom software, we can help!
In the past three decades, tremendous progress has been made in the fight against cancer, but there is still so much more work to be done. At Deciphera, we remain steadfast in our mission to improve the lives of people living with cancer - and that passion for making a difference extends to the patient groups and communities in which we live and work.
During the COVID pandemic, Fynydd partnered with Blue Sequoyah Technologies (https://bluesequoyah.com) to build Coursabi: a cutting edge learning platform (https://coursabi.com). It's an all-in-one learning solution with features like native and SCORM course support, video conferencing, audio and video libraries, forms, reports, events, and more, all presented as a concise learning journey.
We found particular success in the pharmaceutical and healthcare space, and are proud to see these clients renewing each year as they find success in keeping their teams trained, compliant, and most of all, happy.
One of our early subscribers, Deciphera (https://deciphera.com), has been at the cutting edge of cancer research for decades. They do great work, and we're proud to say that they have renewed their Coursabi subscription for 2025!
There's usually more to the story so if you have questions or comments about this post let us know!
Do you need a new software development partner for an upcoming project? We would love to work with you! From websites and mobile apps to cloud services and custom software, we can help!
Planning out a long-term strategy for your web project can really pay off. We were recently reminded of that when we were asked to create a mobile app (iOS and Android) for a web-based platform we designed and built several years ago. The platform is Coursabi, a learning platform that ensures growth at each milestone for everyone on your team. You can check it out at https://coursabi.com.
Desktop view of the Coursabi dashboard.
When we created the technical strategy we knew that a mobile app was a likely roadmap item. So we chose ASP.NET Blazor as the core platform technology. It allowed us to build a web app that felt like a single page app (SPA). And it gave us several hosting models: server, WASM (WebAssembly), and hybrid mobile. The most intriguing aspect of the Blazor Hybrid model is that unlike hybrid apps of the past, there is no web server running on the mobile device. Instead, all the C# code is compiled to native .NET code, and the web view (an embedded web browser) is only used to render the user interface. So the app runs as a native mobile app!
Various mobile (phone) views.
We knew that some features of the platform would have to be altered, since the mobile app has no web server. For example, Coursabi supports the SCORM format for external learning content. And due to security restrictions, they needed a host with a trusted root certificate. So moving that out of the platform and handling the routing changes were both necessary, but totally doable.
Another benefit of a mobile app version of the platform is that in many ways it also simplifies the security model, since the app is only running on the local device, whereas a hosted app needs to manage user state, among other concerns.
Tablet view is a hybrid of desktop and mobile.
If you have an ASP.NET-based web application, you can still leverage Blazor Hybrid to turn it into a mobile app. It just needs to first be migrated into a Blazor app. I'd also recommend reviewing your web app for opportunities to make it as mobile-friendly as possible. You don't want your mobile app to look or feel like a website. But those changes not only get you a great mobile app, they also improve how your app looks and feels in a mobile web browser. So you get twice the value.
There's usually more to the story so if you have questions or comments about this post let us know!
Do you need a new software development partner for an upcoming project? We would love to work with you! From websites and mobile apps to cloud services and custom software, we can help!
Fynydd partnered with Blue Sequoyah Technologies to build a community-driven learning platform named Coursabi, which gives learners a simple but powerful way to grow as they follow their learning journey. Their dashboard shows them progress to-date and what assignments are next. They can explore the content library for elective learning, sign documents, and complete forms. And the community gives them a way to learn from peers and content authors.
Coursabi Mission Control is where authorized users can create and organize training content like documents, forms, and courses. There are also libraries for audio and video content, as well as imported learning modules. People and learning assignments are managed here. And administrators and training managers can stay up-to-date using dashboards, reports, notifications, community activity, and so much more.
Blazor
C#
CSS3
HTML5
JavaScript
Microsoft .NET
Sass/SCSS
Amazon Web Services
C#
Github
Microsoft .NET
Microsoft Windows
SQL Server
There's usually more to the story so if you have questions or comments about this post let us know!
Do you need a new software development partner for an upcoming project? We would love to work with you! From websites and mobile apps to cloud services and custom software, we can help!
Bossier-Parish Community College campus, Bossier City, LA.
Fynydd was asked to build a hybrid iOS, Android, and web-based learning app platform for enrolled and public students at Bossier Parish Community College (BPCC) in Bossier City, Louisiana. This was a full-stack platform that included a data tier, API service with management interface, client apps (App Store, Google Play Store), and responsive website.
The goal of the project was to research the efficacy of gamification strategies with regard to testing up and testing out of courses prior to enrollment. Secondarily it provided a great way for students to study and hone their knowledge during each semester.
The platform provided various curriculum through video courses, which each had check your knowledge quizzing as students progressed. Students could earn badges as they advanced through their learning journey and also challenge each other to quiz games for additional badges and bragging rights via a leader board.
Some of the features of the platform include:
Android
Angular
CSS3
HTML5
Ionic Framework
iOS
JavaScript
Sass/SCSS
Amazon Web Services
C#
Github
Microsoft .NET
Microsoft Windows
React
SQL Server
There's usually more to the story so if you have questions or comments about this post let us know!
Do you need a new software development partner for an upcoming project? We would love to work with you! From websites and mobile apps to cloud services and custom software, we can help!
COS has partnered with the Pentagon, the Department of Defense, and over 20 U.S. military bases to achieve increased knowledge, empathy, and improved bystander engagement over the last 30 years.
Campus Outreach Services offers unmatched sexual assault prevention training, substance use programs, mental health school assemblies, college transitions workshops, and customized series of other wellness topics. With compelling presenters and pragmatic resources, our impact lasts beyond an hour, a week, a year. We deliver pin-drop moments for lifetime change.
Campus Outreach Services partnered with Fynydd to create an analytics dashboard for their ThinkDrink learning platform. They needed to show efficacy across demographics and teams including longitudinal test results for their ThinkDrink program.
The platform enables subscribers to track course completion, filter, compare and share results, and see overall efficacy.
Some of the key features of the project include:
CSS3
HTML5
JavaScript
Sass/SCSS
Github
Moodle
MySQL
PHP
There's usually more to the story so if you have questions or comments about this post let us know!
Do you need a new software development partner for an upcoming project? We would love to work with you! From websites and mobile apps to cloud services and custom software, we can help!
The Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit organization that develops laboratory standards worldwide. Our standards are recognized by laboratories, accreditors, and government agencies as the best way to improve medical laboratory testing.
CLSI partnered with Fynydd to create a web platform for marketing their organization, provide member and volunteer services, membership management, and a shop for their Standards documents.
The platform integrated with NetForum and other third party services to provide a single, complete access portal for staff, members, and volunteers.
The shop provided unique pricing, options, and user experiences for anonymous visitors, members, and customers in developing countries. Standards products provided digital samples and full specifications, as well as customized pricing based on the visitor.
A member portal provided everything a member needs to manage their profile, membership details, purchase history, downloadable products, event attendance, membership certification, nominations, volunteer history, and more. It also provided delegates with management tools for authorized employees in their account.
Other tools and features include public file management for volunteer communication and education, outbound links to services such as their eClipse platform and support system, a shopping cart reminder system, product import and publication tools, and so much more.
Some of the key features of the platform include:
CSS3
HTML5
JavaScript
Sass/SCSS
C#
Github
Microsoft .NET
Microsoft Azure
Microsoft Windows
NetForum
SQL Server
Umbraco CMS
There's usually more to the story so if you have questions or comments about this post let us know!
Do you need a new software development partner for an upcoming project? We would love to work with you! From websites and mobile apps to cloud services and custom software, we can help!
The U.S. Department of Justice through the Department of Alcohol, Tobacco, Firearms, and Explosives (ATF) partnered with Fynydd to create a secure web portal for their Office of Science and Technology directorate.
The platform was built using the Microsoft SharePoint ITAR platform under the most strict security protocols. This platform is built and configured specifically for secure government use.
Access to this environment required rigorous background checks at the state and federal level for each Fynydd development team member. And the subset of SharePoint functionality offered by ITAR made building in the environment a challenge. In addition, some of our work required travel to meet with the OST team in Washington D.C.
Some of the key details of the project include:
CSS3
HTML5
JavaScript
Sass/SCSS
C#
Github
Microsoft .NET
Microsoft Azure
Microsoft SharePoint
Microsoft Windows
SQL Server
There's usually more to the story so if you have questions or comments about this post let us know!
Do you need a new software development partner for an upcoming project? We would love to work with you! From websites and mobile apps to cloud services and custom software, we can help!
