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!
Cloud storage services, like Google Cloud Firestore, are a common solution for scalable website and app data storage. But sometimes there are compliance mandates that require data services to be segregated, self-hosted, or otherwise provide enhanced security. There are also performance benefits when your data service is on the same subnet as your website or API. This is why we built the Datoids data service.
The Datoids data service is a standalone platform that can be hosted on Linux, macOS, or Windows. It uses Microsoft SQL Server as the database engine, and provides a gRPC API that is super fast because commands and data transfers are binary streams sent over an HTTP/2 connection. In addition to read/update/store functionality, it also provides a freetext search. We've been using it in production environments with great success.
Although the API can be used to completely control the platform, Datoids also includes a separate web management interface. It provides a way to configure collections, API keys, and even browse and search data, and add/edit/delete items. We've embedded Microsoft's simple but powerful Monaco editor (the same one used for VS Code) for editing data.
The architecture is clean. Projects are organizational structures like folders in a file system. Collections act like spreadsheets (or tables in SQL parlance) filled with your data. There are also service accounts that are used to access the data from your website or app.
To make using it as easy as possible, we built a .NET client package that can be included in any .NET project, so that using Datoids requires no knowledge of gRPC or HTTP/2, since reading and storing data is done using models or anonymous types.
Getting a value from Datoids is simple:
Likewise, storing data is just as easy.
You can also modify data without replacing the entire object.
There are plenty of other ways to read and write date as well, combining primary key and native query options. You can even perform bulk transactions.
If you have a website or app platform that needs a robust and performant data service, let us know! We can provide a demo and answer any questions.
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!
Fynydd was founded 15 years ago in June of 2010 as an onshore web and software development company. The tech industry has changed quite a bit over that time (I'm looking at you, AI), but all along we've been helping organizations thrive with web and native software development services that support their marketing, products, and operations.
In the beginning we were challenged with navigating a web dominated by Internet Explorer. Google Chrome had only been available for a couple years at that time (and only had about a 9% market share), and each browser had a different (and in many ways incompatible) rendering engine. Building websites that behaved properly across them all resulted in a lot of wasted time. And that was just desktop web browsers.
In that same year Apple only had a single phone: the iPhone 3GS with iOS 4. And Samsung introduced a new device, the Galaxy S. Android had only been available for a couple years at that point, and Google released the 6th version (Froyo) with Adobe Flash support! Egads.
Left to right: Apple iOS 4 and Google Android Froyo
We got off to a running start! One of our notable clients back then was US Bank, who partnered with us to analyze how they could revamp their internal knowledge management architecture to better handle acquisition data, and also create a better support system for bank branch employees. This lead to a two phase engagement that culminated in two printed books outlining the state of their technology and our recommendation for moving forward.
We built marketing websites, sales tools, and online stores for other early clients like EP Henry (hardscaping), Philadelphia Scientific (battery management), and VWR International (life sciences). Some of our earliest clients remain with us today.
As I wrote in the introduction, the industry has changed quite a bit since 2010 and we love it! There's so much to learn and explore, of course, including generative AI, machine learning (ML), and large language models (LLM), and how they can provide new opportunities for organizations to grow and adapt.
So if you need web and app development help, we'd love for you to be in the next chapter of our story!
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!
We'll be presenting the following topic at the 2012 UK Semantic Tech & Business (SemTech) Conference:
Building a Semantic Enterprise Content Management System from Scratch
2012 UK Semantic Tech & Business Conference
Millennium Gloucester Hotel, London, England
Thursday, September 20, 3:45-4:15 PM
Detail on our program is available on the SemTechBiz UK 2012 site. The conference runs September 19-20. We hope to see you there!
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 early June, Fynydd was invited to speak at the 2012 Semantic Tech & Business Conference in San Francisco, California. By all accounts, Fynydd’s message was unique, informative, and overall very well received by conference attendees.
The topic “How To Build a Sematic Content Management System From Scratch” garnered much interest even before the conference began. During our presentation, we outlined a case study based on a recent Fynydd client engagement. We walked through the successes and challenges Fynydd faced in designing and implementing a semantic prototype system for a large financial institution.
Though primarily invited as a speaker, Fynydd also secured a location on the exhibit floor of the conference so that we could present our full breadth of services to conference attendees. Activity at the exhibit was bustling. Attendees remarked about Fynydd's unique set of service offerings, as well as how we worked with other exhibitor products to build holistic solutions for our clients. Conversations focused heavily on user interface design and overall user experience as well as implementation of semantic technologies across a wide variety of industries and projects.
With the success of this conference, Fynydd was asked to present at the SemTechBiz satellite conference in London later this year. You can find out more by visiting the Fynydd SemTech page and the SemTechBiz London site.
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!
