Build a new QMS
OZQA combines ready made Quality frameworks with hands on implementation support to get your Quality Management System up and running faster. Choose a QMS solution designed around your industry and development stage. We customise the documentation, help implement the system, train your team and support you through the transition to daily operation.
BUILD FASTER. START AHEAD.
Start with the QMS you need today.
Your Quality requirements change as your organisation develops. Our QMS solutions are structured around where you are now, so you can establish the processes you need today and upgrade your system as your responsibilities grow.
COMPLETE
QMS SOLUTION
Starting from scratch?
Build a complete clinical Sponsor QMS with OZQA.
Ideal for:
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For organisations that need to establish the full quality framework for clinical development.
From €11,950
Additional consulting support can be added if your organisation requires further customisation or implementation activities.
ADDITIONS
QMS SOLUTION
Already have a foundational QMS?
Add the Phase I/II module.
Ideal for:
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Existing OZQA Preclinical QMS customers
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Companies with established core quality processes but limited clinical Sponsor procedures
From €11,950
Additional consulting support can be added if your organisation requires further customisation or implementation activities.
MORE THAN A DOCUMENT PACKAGE
We don't just hand over SOPs.
A set of Quality documents is not the same as an operational Quality Management System.
That is why our Build QMS solutions combine ready made Quality content with implementation support. We adapt the framework to your organisation and help translate the documentation into responsibilities, processes and day to day Quality activities.
DOCUMENTS ARE ONLY THE BEGINNING
Documents are only the beginning.
A set of Quality documents is not the same as an operational Quality Management System. That is why our Build QMS solutions combine ready made Quality content with implementation support. We adapt the framework to your organisation and help translate the documentation into responsibilities, processes and day to day Quality activities.
Stop paying consultants to start from a blank page.
A DIFFERENT WAY TO BUILD QUALITY
Traditional consulting projects often begin with a blank page. Consultants research requirements, draft each document, review it with the organisation and revise it before implementation can even begin.
We have already done much of that work. OZQA has developed Quality frameworks and documentation that can be used as the starting point for new Quality systems. Instead of charging you to recreate standard Quality content, we focus our consulting time on the parts that need to be specific to your organisation.
NOT SURE WHERE TO START?
Find out where you stand.
Your development stage is only one part of determining the appropriate Quality system. Your activities, outsourcing model, organisation, products and upcoming milestones also matter. Tell us where you are today and what comes next. We can help determine the appropriate scope before you commit to a solution.
YOUR NEXT MILESTONE
Quality solutions built around where you are.
OZQA combines proven quality frameworks, ready-to-adapt documentation and experienced Quality professionals to help you move forward without starting from scratch. Choose the solution that fits where you are today.
Improve QMS
Keep what works. Fix what does not. We identify quality gaps, simplify processes and strengthen your existing quality management system.
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Outsource QA
Access experienced outsourced Quality professionals without the cost and commitment of building a full internal QA department.
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Digitalise QMS
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PREFER TO IMPLEMENT IT YOURSELF?
Start with our ready made Quality documentation.
If you already have the Quality expertise and resources required for implementation, you can purchase individual Quality documents or complete documentation packages without implementation support.
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