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Regulatory Requirements? 

Experts in Change Management, 

Quality Dashboards

& Lot Traceability

Compliance Services

Explore our range of areas including Change Control, Documentation, Training & Awareness, and Audits. We seamlessly implement solutions, forms, and platforms that meet regulatory requirements and balancing operational controls.

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We are committed to delivering high-quality, affordable solutions tailored to your business.

Laboratory

Change Management

We provide and help you navigate compliant change management processes. It starts with documenting the change, communicating the plan, and implementing the corrective action/preventive action. Proper Change Management looks and feels like everyone is informed and knew exactly when it was going to happen. 

Lab Experiments

Training & Awareness

Inadequate work instructions?

Our "Operational Excellence Training System" helps download crucial operators' brains, document what makes things so special, and train up others in a comprehensive package. Whether it's machines, product, or QMS, we create new SOP's, make reference guides and training materials, with photos, videos, presentations and tests to help you develop employees.  

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Thorough Audits

With ISO 13485 and 9001 Lead Auditor Certified, we know what we're looking for and ready to implement. Audits and Gemba walks are conducted to identify areas for improvement and ensure regulatory compliance.

Experienced in several regulatory agencies, trust us to provide thorough audit reports, recommendations, and how to implement in your organization.

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