Building a Unified QMS for a Non-Profit Lab Organization
Building a Unified QMS for a Non-Profit Lab Organization
Non-profit organization
Software Solutions & Services
Pharma & Biotech
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A large non-profit organization operating in the healthcare and laboratory space set out to unify and digitize its quality management processes. With numerous departments and legacy systems in place, the client aimed to improve compliance, efficiency, and consistency by implementing a single, validated SAAS Quality Management System (QMS).
1
Challenge
2
Approach
3
Results
Challenge
Aligning processes across departments
The organization faced a key challenge: aligning quality processes across a wide range of departments, each using their own legacy applications.
They needed to:
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Standardize workflows for core quality processes;
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Implement and validate a centralized QMS application;
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Ensure the transition didn’t disrupt daily operations;
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Migrate existing documentation into the new system;
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Meet regulatory requirements through proper validation.
A solution was required that was both structured and flexible, capable of supporting change across the entire organization.
Approach
From process mapping to validation
QbD Group joined the project in late 2023, assigning a dedicated QMS expert to take the lead. We started with an in-depth analysis of current practices across departments, working closely with stakeholders to define generic quality workflows. These covered areas such as:
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Documentation control
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Training management
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CAPAs (Corrective and Preventive Actions)
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Change control
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Quality events
Once aligned, these workflows formed the foundation for clear user requirements and the configuration of the SAAS QMS solution.
We developed a document migration strategy to ensure relevant data could be uploaded or created in the new system. Our expert led the validation of the application, ensuring compliance with both GAMP®5 guidelines.
Results
A ready-to-use, compliant QMS
By the end of the project, the client had:
- A complete set of standardized quality workflows across the organization;
- A configured and validated SAAS QMS, ready for immediate use;
- Initial data and documentation uploaded to support daily operations from day one;
- A system validated against industry standards, ensuring full regulatory compliance.
This collaborative project laid the foundation for a stronger, more consistent quality culture, supported by modern digital tools and aligned processes, all delivered with the flexibility, expertise, and structure.
Get in touch
Ready to streamline your quality processes?
Whether you're aligning workflows across departments or preparing for a digital QMS rollout, we’re here to help.
Get in touch with our experts to discuss how we can support your quality transformation.
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