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.

Why 21 CFR part 11 matters

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 validation journey

1. Understanding the Regulatory Landscape

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.

2. Executing IQ, OQ, and PQ testing

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.

3. Implementing procedural controls

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.

4. Documenting and closing the validation

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.

Key takeaways

1. Validation is a team effort — involving developers, quality experts, and end-users.

2. Documentation is as important as the software itself — if it’s not documented, it didn’t happen.

3. Compliance is ongoing — system updates, infrastructure changes, and new features require periodic re-validation.

What this means for our customers

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.

Want to know more?

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!