BIOQUAL: How a Fast-Growing CRO Eliminated Paper, Strengthened GLP Compliance, and Saved Months of Administrative Time with ZenQMS

A Growing CRO Confronts the Limits of Manual Quality Management

When Emily Love joined BIOQUAL as Corporate Training Manager, she inherited workflows held together by paper, spreadsheets, and interoffice routing. Training sign-ins were handwritten. SOP acknowledgments required printing, initialing, and circulating through physical mail. Deviations moved slowly from person to person. As BIOQUAL continued to grow, these processes strained under the increasing volume of studies and documentation.

“It was very, very manual, lots of paper-based systems, and really inefficient Excel spreadsheets that weren’t meeting our needs.”

Nowhere was this more evident than during year-end training reconciliation. For a GLP-aligned operation, confidently confirming training completion is essential, yet the process had become overwhelming.

“At the end of the year, it took a solid two months to determine who still had training left to do.”

The need for a modern electronic quality management system (eQMS) that could unify training, documents, deviations, and compliance became undeniable.

Choosing an eQMS Built for GLP Workflows

BIOQUAL’s selection criteria reflected the realities of working in a regulated CRO environment. The team needed a system that supported:

• Document control
• Training and role-based assignment
• Deviations and quality events
• 21 CFR Part 11-compliant electronic signatures
• A validated, audit-ready foundation

ZenQMS met every requirement. The platform connected all core quality workflows in a single system, and BIOQUAL could configure each module to match existing processes rather than rebuild them from scratch.

Validation was a major factor. As a GLP-aligned organization, BIOQUAL needed to ensure the system was compliant and defensible from day one. ZenQMS provided the complete validation package upfront – including qualification checklists, UAT templates, and GAMP 5–aligned documentation – without extra fees or outsourced services. The validation path was straightforward and removed a major barrier to implementation.

ZenQMS also stood out for its functional completeness.

“We looked for a system that did document control, training, and deviations. Some programs would do one or two, but not all three.”

With validation support, unified workflows, and a life-sciences-specific design, BIOQUAL had confidence that ZenQMS would support both current and future needs.

A Smooth, Phased Implementation for Nearly 200 Employees

ZenQMS guided BIOQUAL through a phased implementation designed for regulated teams. The structured approach helped BIOQUAL prepare thoroughly, test intentionally, and introduce each module at a manageable pace.

“The way implementation was structured in phases was very, very helpful.”

BIOQUAL went live in mid-April. Throughout May, Emily trained nearly 200 employees to use the system. She developed a full training presentation using screen recordings from both the sandbox and production environments, ensuring every user learned the system in a consistent way.

By the end of the rollout, the entire organization had transitioned to ZenQMS with shared clarity around how to access tasks, complete training, and navigate their dashboards.

Training, SOPs, and Deviations: A Real Shift in Daily Work

Once ZenQMS was fully implemented, BIOQUAL saw meaningful improvements across its quality workflows, particularly in training, SOP acknowledgment, and deviation management. Each area benefited from clearer visibility and streamlined execution.

Training Becomes Clear, Fast, and Fully Visible

Employees could now see exactly what training was required the moment they logged in. Supervisors gained real-time oversight, reducing the need for manual check-ins or reminders. The dashboard visuals even changed employee behavior, encouraging earlier completion.

“People really do like the color pie chart on their training dashboard. They always tell me, ‘I’m in the green, Emily!’”

The administrative payoff was substantial. Tasks that once required months of sorting, reconciling, and re-checking could now be completed with a few simple reports.

“For as big a company as we are – 200 employees – it used to take two months. I feel like now it will take about a day or two.”

With training under control, other improvements came into clearer focus.

SOP Acknowledgments Without the Paper Chase

SOP management saw one of the biggest shifts after BIOQUAL implemented ZenQMS. Under the old system, acknowledgments required printing a form, initialing and dating it, sending it through interoffice mail, and filing it manually. That process slowed down revisions, complicated version control, and made it difficult to ensure employees were trained on the correct SOPs – a critical expectation for any GLP-regulated CRO.

“It was asking far too much to print out a piece of paper and date and initial it and send it through office mail… just to acknowledge one document.”

With ZenQMS, that friction disappeared. SOP updates now trigger automated assignments tied directly to each employee’s role, ensuring people only receive the SOPs and training that apply to their work. Emily explained that this shift has made users more engaged because the content is finally relevant to what they do. Managers can also easily confirm that staff are trained on the correct version of each SOP, something that was nearly impossible in the previous system.

“Now that I can make everybody have their own role… people are much more willing to do their work because it is relevant to them.”

Today, BIOQUAL stays fully aligned with the SOP right versions, and Emily says going back to the old process wouldn’t be feasible.

Deviations Move at a Much Quicker Pace

The Issues module also brought much-needed clarity. After an additional round of supervisor training, deviations began flowing through digital workflows instead of physical mail. Quality gained visibility, and employees gained a more intuitive process.

“People really appreciate the ease and simplicity of not having to do interoffice mail for these paper forms.”

Together, these improvements brought cohesion, consistency, and transparency to BIOQUAL’s quality operations – supporting the GLP rigor their research demands.

A Quality System That Scales With BIOQUAL’s Research

Reflecting on the cumulative impact across training, SOP management, and deviations, Emily emphasized the measurable time and resource savings for both the quality team and the broader organization.

“In terms of hours alone… the work of the administrators and the incremental value across each employee is a huge savings of time and resources.”

Her summary of the system’s value captures the transformation:

“ZenQMS is essentially worth a full person or two of administrative effort just in the training and quality departments – plus a huge incremental time savings for every single employee who can now find, complete, and track their training and quality tasks quickly in one place.”

For BIOQUAL, ZenQMS was more than a move away from paper. It delivered a quality system that finally matched the sophistication, pace, and regulatory expectations of their scientific work.

Want to see how ZenQMS can work for you? Watch our 3-minute demo for a quick look at simple and compliant quality management software.