Building a Unified QMS for a Non-Profit Lab Organization

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:

• Standardize workflows for core quality processes;

• Implement and validate a centralized QMS application;

• Ensure the transition didn’t disrupt daily operations;

• Migrate existing documentation into the new system;

• Meet regulatory requirements through proper validation.

A solution was required that was both structured and flexible, capable of supporting change across the entire organization.

Discover our approach

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:

• Documentation control

• Training management

• CAPAs (Corrective and Preventive Actions)

• Change control

• 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.

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Result

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.

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