How HungaroTrial Centralized CRO Quality Management and Improved Audit Readiness with ZenQMS

Success Highlights:

• Centralized SOPs, training, audits, quality workflows, and vendor qualification in one eQMS
• Reduced manual follow-up for QA through dashboards and automated reminders
• Improved audit and inspection readiness with controlled access to quality records

“Everything is now in one place. Our follow-up time has decreased because we do not have to chase people manually for training, CAPAs, SOPs, or QMS documents.” - Santosh Sacket, Quality Assurance Director, HungaroTrial

For a contract research organization (CRO), quality is part of every project, process, and sponsor relationship.

HungaroTrial, a CRO headquartered in Budapest, has supported clinical research since 1999. Today, the company conducts Phase I through Phase IV clinical trials across therapeutic areas including oncology, respiratory, cardiovascular, arthritis, and other indications. As the organization has grown, HungaroTrial has expanded across multiple regions, with teams in Europe, the United Kingdom, the United States, and Asia.

That kind of growth brings more complexity to quality management. As HungaroTrial expanded, its QA team needed a more connected way to manage core quality activities, including:

• Controlling SOPs and QMS documents
• Assigning and tracking training
• Supporting sponsor audits and regulatory inspections with accurate records
• Qualifying vendors and subcontractors
• Moving quality issues, CAPAs, and change controls through defined workflows

As Quality Assurance Director, Santosh Sacket oversees HungaroTrial’s Quality Management System (QMS). He supports internal and sponsor audits, manages SOPs, forms, and templates, and provides quality-related training to help ensure compliance and consistent processes.

His team also helps ensure employees across the organization are following applicable SOPs, GCP requirements, and regulatory expectations.

To support that work, HungaroTrial uses ZenQMS as a centralized eQMS for managing quality processes across teams, projects, and regions.

CRO quality management across a growing global organization

Before implementing ZenQMS, HungaroTrial relied on a combination of SharePoint, internal network folders, and working libraries to manage SOPs and quality documents.

Teams could access documents, but the process depended on more manual coordination. When an SOP needed to be created or revised, documents were often routed by an internal network folder. One reviewer would provide comments, then the document would move to the next person. That sequential process could slow down review cycles and create more follow-up work for QA.

For a growing CRO, that type of manual process can become difficult to sustain.

HungaroTrial needed a more structured way to manage the full lifecycle of quality documents, from drafting and review to approval, training, and ongoing tracking. The team also needed better visibility into pending tasks, overdue training, audit timelines, vendor qualification status, and other critical-to-quality activities.

With ZenQMS, HungaroTrial brought those processes into one connected quality management system.

Centralized eQMS for documents, training, and QA oversight

ZenQMS gave HungaroTrial a single platform for managing documents, training, issues, change control, audits, and reporting.

Instead of relying on scattered folders, the QA team can now draft documents, assign co-authors, manage review workflows, approve final versions, and assign required training within the same system. Multiple contributors can collaborate through the workflow instead of waiting for a document to move from one reviewer to another.

For Santosh, that has helped save time and reduce manual effort.

ZenQMS has also become part of his daily QA routine. When he logs in, he can see what is pending, review company dashboards, check training status, and identify where follow-up may be needed. Automated email alerts notify users when they have assigned tasks, training, CAPAs, quality issues, document workflows, or other items requiring action.

That visibility has reduced the need for QA to manually chase people for every open item.

Training management with clearer accountability

For training management, this is especially important. HungaroTrial uses ZenQMS to support training across multiple departments, and QMS document training managed by QA.

That gives one place to assign, track, and follow up on required training. QA can manage training tied to SOPs, policies, regulatory summaries, and project-related materials, and employees can see what they need to complete and when.

The system also helps employees and process owners stay aware of their own responsibilities. Instead of relying entirely on manual QA or HR reminders, users receive automated alerts and can track their assigned training directly in ZenQMS.

“ZenQMS is really user-friendly, and our team is now well-versed in the system.” - Santosh Sacket, Quality Assurance Director, HungaroTrial

Strengthening audit and inspection readiness

Audit and inspection readiness is a major part of HungaroTrial’s quality operations.

As a CRO, HungaroTrial needs to be ready for sponsor audits and regulatory inspections. That means the QA team needs a reliable way to show evidence, provide access to relevant records, and demonstrate that quality processes are controlled.

ZenQMS helps the team manage that work with more visibility and structure.

For audits, HungaroTrial can upload audit plans, assign process owners and audit team members, track audit dates, and manage response deadlines. Auditees receive notifications when audit plans are uploaded or when CAPA responses are due, helping keep teams aligned on expectations and timelines.

ZenQMS also helps HungaroTrial provide controlled access to key quality documents during sponsor audits and regulatory inspections. When sponsor auditors need to review SOPs before or after an audit, HungaroTrial can grant temporary restricted access (read only) for a defined period of time. Auditors can review the documents they need directly in the system, while HungaroTrial maintains control over access and timing.

“Sponsor auditors and regulatory inspectors can access the SOPs, policies, forms, and templates they need directly in ZenQMS. It makes the process easier for them to review and easier for QA to manage.” - Santosh Sacket, Quality Assurance Director, HungaroTrial

The same approach has supported regulatory inspection activity. During a recent Hungarian regulatory inspection, HungaroTrial provided inspectors with access to ZenQMS so they could review relevant policies, SOPs, forms, and templates.

For Santosh, that controlled access is a huge advantage. Instead of pulling records from different folders or sharing documents manually, HungaroTrial can use ZenQMS as a secure, cloud-based source of truth for quality documentation.

For auditors and inspectors, information is easier to review. For QA, the process is easier to manage. 

Managing vendor qualification in the same eQMS

HungaroTrial also uses ZenQMS to support vendor qualification, a critical quality process for CROs working with external partners.

Clinical research projects often require support from translation agencies, laboratories, hospitals, shipping partners, and other subcontractors. Before a vendor can be used, QA may need to complete a vendor qualification assessment.

With ZenQMS, HungaroTrial has brought that process into a defined workflow.

When a project manager wants to use a vendor that has not yet been qualified, the request can be submitted for QA review. The QA team then conducts the assessment, documents the outcome, and provides the project management team with the vendor’s status.

The record shows:

• When the vendor qualification request was received
• When QA completed the assessment
• The outcome of the review
• Whether the vendor is suitable for use

HungaroTrial also maintains its qualified vendor list in ZenQMS, making it easier to download and share vendor information with sponsors, auditors, or inspectors when needed.

“If an auditor or inspector wants to see how we handle vendor qualification, we can download the report and show the full process, from the request to the QA assessment and outcome.” - Santosh Sacket, Quality Assurance Director, HungaroTrial

This gives HungaroTrial a clearer way to show how vendor qualification is managed from request to outcome. Instead of piecing together evidence from multiple locations, the QA team can provide the supporting records from one system.

An eQMS recommendation backed by real QA confidence

For HungaroTrial, ZenQMS is more than a place to store documents.

It supports daily QA oversight, document control, training management, audit preparation, vendor qualification, and collaboration with sponsors and inspectors. It also gives HungaroTrial a more controlled way to manage quality records across teams, regions, and projects.

That confidence has extended beyond HungaroTrial’s own use of the system.

HungaroTrial has been willing to share its experience with other organizations evaluating eQMS solutions, offering the kind of peer perspective that can be especially valuable in regulated life sciences environments. For companies deciding whether to adopt a new quality management system, hearing from another organization that uses the system in real QA operations can help validate whether the platform will work in practice.

“I definitely recommend ZenQMS to other sponsors, CROs, or laboratories looking for an eQMS solution.” - Santosh Sacket, Quality Assurance Director, HungaroTrial

For Santosh, the reasons are practical: ZenQMS is user-friendly, supported by a responsive team, cost-effective, and capable of bringing quality workflows into one controlled system.

As HungaroTrial continues to grow, ZenQMS gives its QA team a stronger foundation for managing quality across teams, regions, projects, sponsors, vendors, and audits.

For a global CRO operating in a regulated environment, that combination of usability, control, and confidence is exactly what a quality system needs to provide.

Ready to simplify quality management?

ZenQMS helps CROs and life sciences organizations bring documents, training, audits, quality workflows, and vendor qualification into one connected eQMS.

Talk with our team to see how ZenQMS can support your quality operations.

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