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From Warning Letter to Controlling Quality: How Bell International Laboratories Strengthened Its Quality System with ZenQMS
About Bell International Laboratories
Bell International Laboratories is a Contract Development and Manufacturing Organization (CDMO) for cosmetics and over-the-counter pharmaceuticals, with sunscreen representing a significant portion of its business. The company supports roughly 80 customers with manufacturing, documentation, and quality processes that need to stand up to both regulatory expectations and customer audits.
Success Highlights
At a glance
Bell International Laboratories used ZenQMS to move from hard-copy quality management to a more controlled electronic quality management system (eQMS) during an FDA warning letter remediation period. With ZenQMS, Bell centralized SOPs and forms, improved training visibility, supported FDA follow-up inspection readiness, expanded quality workflows, improved customer audit support, and continued building a culture of quality excellence after the warning letter was lifted.
Responding to an FDA Warning Letter with a Manual Quality System
When Paul Weiss joined Bell in September 2024, the company was several months into responding to an FDA warning letter.
The quality team was working under pressure. Bell needed to strengthen its quality system, improve documentation control, and show that corrective actions were becoming part of the way the business operated.
Much of the work was still happening on paper:
- Batch review relied on hard-copy records.
- Training records lived in folders.
- Documentation was difficult to find.
- Follow-up depended heavily on emails, reminders, and individual effort.
When records are scattered and follow-up is manual, even strong teams can struggle to prove the work they are already doing. During an FDA inspection or customer audit, proof matters. Teams need to find the right record, show the right training, and demonstrate control when it counts.
That was the starting point for Bell’s quality transformation with ZenQMS.
The Challenge: Proving Control with Paper-Based Quality Processes
Before ZenQMS, Bell’s training process showed the limits of hard-copy quality management. Teams would send an email asking employees to train on a document, sign off, and return the record to a folder. Without an electronic quality management system to assign training, track completion, and trigger follow-up, Bell had limited visibility into who had completed required training and who still needed attention.
“Training was one of the clearest problems. We had hard-copy folders, email reminders, and no reliable way to make sure everyone completed what they needed to complete.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
The documentation challenge was just as important. In a regulated environment, records need to be complete, current, controlled, and easy to retrieve. Bell needed a system that could help the team quickly find SOPs, forms, training records, and quality documentation when regulators or customers asked for evidence.
That is exactly the kind of pressure ZenQMS is built to relieve. Quality teams spend countless hours keeping their companies compliant. ZenQMS helps make that work easier to track, easier to find, and easier to prove when audit or inspection time arrives.
For Bell, the need was clear: one consistent quality system that could support FDA expectations, customer audits, and internal accountability.
The Response: Moving Document Control and Training into ZenQMS
Bell launched ZenQMS in February 2025 with its core SOPs, forms, and document categories. The team started with the areas that would help create immediate control: document management, training records, revision control, and easier access to the records people needed most.
Over the next year, Bell expanded to 28 document categories in ZenQMS, bringing more of its quality system into one controlled environment.
For Paul, who had previously worked with more complex systems, ZenQMS was easier to learn, configure, and administer. He could set up document categories, manage custom fields, connect roles to training, and shape the system around Bell’s actual processes.
“I had used more arduous systems before. ZenQMS was much easier to pick up, and it gave us the ability to configure what we needed ourselves.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
ZenQMS is designed to be simple for users and powerful for administrators. For Bell, that meant the quality team could configure the system around the way they worked. Attachments, links, category-specific custom fields, and conditional fields helped Bell move away from hard-copy processes while keeping related records, SOPs, forms, and data connected.
The FDA Follow-Up: Showing Progress Toward a Controlled eQMS
When the FDA returned for a follow-up inspection, Bell was still early in its ZenQMS journey (the company had core documents and training in the system, while more advanced workflows were still in development) but the difference was huge.
SOPs and forms were easier to find. Training records were easier to show. ZenQMS helped Bell respond more effectively during that stage of the remediation effort, and the organization could demonstrate that they’d moved away from a hard-copy system toward a more controlled electronic quality management system.
“When the FDA came back, we could find SOPs and forms more easily, and we could show training more clearly.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
Paul said Bell’s move to ZenQMS helped the FDA walk away confident that the company was committed to improving its quality system.
“The FDA knowing we had moved to ZenQMS and were continuing to build with it was a big plus. They could see we were putting a better system in place.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
Bell’s team led the remediation work. ZenQMS helped the team organize records, demonstrate progress, and show that Bell was investing in a more controlled way to manage quality.
In February 2026, Bell’s FDA warning letter was lifted. For the organization, it marked a major milestone in a larger quality transformation.
Building Momentum with Configurable Quality Workflows
After Bell established its document and training foundation, the team expanded deeper into ZenQMS workflows.
In February 2026, Bell launched seven workflows at the same time, including for nonconformances, out-of-specification events, CAPAs, change controls, pest sightings, and annual product reviews. Since then, the team has continued adding workflows for other quality processes.
The workflows helped Bell move from manual follow-up to clearer ownership, stages, approvals, notifications, and evidence.
One example is Bell’s rejection workflow. When a product disposition is rejected, the workflow:
- Alerts the chief operating officer
- Notifies finance
- Informs planning so inventory can be updated
- Retains documentation that the product was discarded
Before ZenQMS, Bell had a hard-copy rejection form, but it was used inconsistently and did not always include the right people or confirm follow-through.
“When a process crosses multiple departments, we want it in a workflow. That gives us a clear path, the right people involved, and evidence that the work was completed.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
Conditional fields also helped Bell improve workflow efficiency and record quality. Users see the fields that apply to the task in front of them, instead of working through unnecessary sections on a hard-copy form.
“With conditional fields, people only see what applies to them. It cuts out the noise and helps them complete the record more efficiently.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
ZenQMS adapts to the way quality teams work. For Bell, that flexibility helped turn cross-functional processes into clear workflows with owners, approvals, notifications, and records of completion.
A Quality Management System People Actually Use
Bell’s ZenQMS environment has continued to grow because teams see new ways to use it.
Paul said employees now come to the quality team regularly with ideas for new workflows. In one example, a team member asked about tracking stability testing. Paul’s team met with the stakeholder, mapped the process, and had a workflow ready to test the next day.
“Now people come to us every week with ideas for new workflows. They see what ZenQMS can do, and they want to bring more processes into the system.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
That adoption matters. An eQMS can only help if people actually use it. Bell was able to build momentum because ZenQMS was configurable enough to match real processes and simple enough for teams to keep using.
“Once you get over the initial hurdle, ZenQMS is very easy to use.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
For Bell, ZenQMS became a practical continuous improvement tool. The team can configure workflows, test them in the sandbox, refine them, and keep building as new quality and operational needs emerge.
Improving Customer Audits and Confidence
As a contract development and manufacturing organization, Bell needs to show customers that its processes, records, and controls are consistent. ZenQMS has helped Bell create a more consistent customer experience.
Paul said customers are pleased to see cleaner, more consistent outputs for deviations, annual product reviews, complaints, and other records. Instead of manually compiling information in different formats, Bell can provide structured exports from ZenQMS.
“Our customers are seeing more consistent outputs now. Deviations, complaints, annual product reviews – they’re cleaner, easier to share, and easier for customers to review.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
ZenQMS also changed how Bell supports customer audits. When clients asked for dozens of SOPs, Bell no longer had to manually locate, download, and send large batches of documents. Paul created an external auditor role in ZenQMS, giving auditors controlled access to the SOPs they need while limiting visibility to the appropriate document set.
“Giving external auditors controlled access to SOPs has worked extremely well. They can find what they need, and it no longer pulls us away to package and send documents manually.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
Bell is also looking to ZenSign to streamline client approvals and reduce the back-and-forth of printing, signing, scanning, emailing, and uploading records.
For Bell, investing in an eQMS helped build trust with regulators and customers by making quality work easier to prove. That is the value of quality done well: stronger processes, better visibility, and more confidence in the records behind the work.
Bell’s Advice for Quality Teams Facing FDA Warning Letter Remediation
For quality teams facing a warning letter, remediation effort, or the pressure of moving from manual processes to an electronic quality management system, Paul’s advice is direct: start with documents, then keep building.
“Be aggressive about getting your documents into the system. Take advantage of training, revision control, and the foundation ZenQMS gives you.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
Once the foundation is in place, begin building workflows.
“Once your document foundation is in place, start building workflows. That’s where you begin connecting the work, the people, and the follow-through.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories
Bell’s journey gives quality teams a practical model for moving from manual processes to a controlled eQMS: migrate documents, use training and revision control, then build workflows that assign ownership and create evidence of follow-through.
“My personal joy is getting rid of clutter and frustration and creating clarity and simplicity.” – Paul Weiss, Associate Director, QS/RC, Bell International Laboratories