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!
In early 2024 Umbraco Commerce (UC) was a relatively new product. It provided features to build a storefront in Umbraco, but we soon discovered that using it was a rough ride. It had glaring bugs, an incomplete feature set, almost no documentation, and was Europe-focused. It was also expensive, especially considering that you have to build your own product browser and cart. Around that time Pentec Health asked us to add a store to the ZOIA Healthcare Umbraco website. Given the state of UC we decided to build our own solution tailored specifically for ZOIA and Umbraco.
The shopping experience is familiar and clean, offering a product browser with categories, pricing, images, and descriptions. Out of stock items are clearly indicated. Paging is used to allow for bookmarking specific filters. And search is centralized and global to the entire store. Visitors are instantly at home.
Viewing a product is also a familiar experience. Staples like product image, clear pricing, and description are front and center. One click add to cart and quantity choices are featured. And when a product is out of stock, authenticated users have the option to be notified when the product is back in stock.
Managing your cart is simple, and when you're ready to check out, the process is straightforward and focused on speed, using simple steps and minimal options. This is one of the reasons we chose to integrate with Stripe for payments. Their flow perfectly fits with our view of what a checkout should be.
And once the order is placed, customers can view the status and order history right from their profile.
The intuitive user experience also extends to the back office. Store configuration options are in one place, including Stripe integration settings, custom shipping methods, page assignments, and contact information. And shopping stages are used to segment orders making them easy to find and process. The stages of an order include: Shopping cart, Payment pending, Paid, Shipped, and Cancelled. Customers are notified of changes in order state so they're always up-to-date.
There is also a powerful coupon code system which allows managers to create a myriad of offers for customers, from simple discounts, to buy one get one (BOGO) specials, free item based on category/price/product, and more.
We also created a dedicated import/export and stock management feature. It allows store managers to export inventory and order data, as well as import current stock levels (replacing stock counts or adding more items) to make updating product availability across the entire store a quick and painless process.
ZOIA is also a premiere provider of renal support food products for local governments and organizations, so their store also has rich B2B support, allowing ZOIA to service various types of organization accounts, large and recurring orders, proxy ordering for organization members, invoiced and deferred payments, and more.
Visit the ZOIA Healthcare marketplace to check it out yourself. If you're interested in a storefront for your products (even if you're not using Umbraco), let us know. We can help!
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!
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!
There is a world full of "build your own website" services that allow just about anyone to stand up a new website in a few hours. Even organizations can leverage the simplicity offered by these services to set up an online store, community, and more. Here are a few examples of why people typically choose these services.
Sounds great! But as with everything in life, there are tradeoffs.
Regardless, these services can be a great way for individuals and small organizations to bootstrap their web presence, and in many cases, you can happily continue to use the service for years.
But there are also long-term lock-in issues that can be more serious, potentially impeding your growth, for example:
If the tradeoffs are too much to swallow, fear not! You can also go with a custom web app tailored specifically to your needs and budget. It can match your vision without compromises and scaling can be managed more easily as your business or traffic grow.
So how do you get started? With a builder service you first have to find one with the price and features you need, and then create an account and dig into their control panel to start configuring your website. Whereas for a custom website the first step is to find a web development partner you can rely on for advice and technical expertise, like Fynydd. Your partner can help gather your ideas, come up with a plan, and build your web app, all within your budget and timeline. They're usually experts in both new web app projects and migrations from other platforms and services. Most importantly, they fill the knowledge gap left by the "build your own website" service.
A web development partner will choose technologies that have a proven security track record. One way we do this is by consulting the CVE database; a publicly funded global resource for tracking common vulnerabilities and exposures. For example, a CVE search quickly reveals that WordPress has historically been a security nightmare.
Your development partner will help you with a design that matches your vision, a hosting service that meets your needs and budget, a security review, a backup plan and disaster recovery strategy, and more. When the time comes to grow your platform, they can help with that too. And throughout the journey you maintain full control over your brand, your website, your data, and your customers.
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!
ZOIA Healthcare is a direct-to-patient provider of specialized nutritional products dedicated to empowering and improving the lives of individuals with inherited metabolic disorders and other rare diseases. They focus on navigating the complexities of healthcare, ensuring patients who require targeted nutrition that cannot be met through a regular diet alone gain access to necessary medical and low protein foods.
Accredited by the Healthcare Quality Association on Accreditation (HQAA), they adhere to stringent standards, helping their patients experience transformative outcomes. Their portfolio is curated to foster advancements in disease management, harnessing the power of nutrition.
ZOIA Pharma partnered with Fynydd to build a new web sales and marketing platform providing patients and organizations with a streamlined shopping experience. Individuals can browse, search, and purchase nutrition products, and even get notified when products are back in stock. And organizations also have the ability to offer a formulary catering specifically to their patients.
Some of the key features of the platform include:
CSS3
HTML5
JavaScript
Sass/SCSS
Amazon Web Services
C#
Github
Microsoft .NET
Microsoft Windows
SQL Server
Stripe
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!
Monitoring Analytics was established in 2008 as the fully independent external market monitor for PJM Interconnection by the Market Monitoring Unit of PJM. PJM Interconnection, a regional transmission organization, ensures the reliability of the electric power supply system in 13 states and the District of Columbia.
Monitoring Analytics (MA) partnered with Fynydd to create a new web platform optimized for a modern user experience.
The goal of the project was to provide visitors with easy access to the Monitoring Analytics quarterly reports and other support documentation, as well as an updated visual appearance.
One of the challenges was the creation of a new taxonomy for their 20 year document collection. It needed to be easy to manage in the back office, but also provide better on-site search results. We were able to work with MA to categorize and organize their document collection and provide a user flow that made finding and downloading documents quick and easy.
Due to various compliance requirements, some aspects of the hosting were non-standard. But we were able to meet all their needs. For example, we deployed the platform CMS without the back office code, and with the CMS management APIs disabled, providing additional security in production. This meant creating a unique publishing workflow whereby a separate instance could be used behind a firewall and approved changes could be deployed through a VPN connection.
Some of the key features of the platform include:
NOTE: THE WEBSITE IS NOT YET LIVE
CSS3
HTML5
JavaScript
Sass/SCSS
Amazon Web Services
C#
Github
Microsoft .NET
Microsoft Windows
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!
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!
