Digitalise your QMS
A digital QMS should do more than store controlled documents.
OZQA helps organisations translate Quality processes into practical digital workflows where documents, responsibilities, approvals, training, records and Quality activities work together.
Already have a paper-based QMS? We can digitalise it. Building a new eQMS? We can design the documentation and digital structure together from the beginning.
DON'T DIGITALISE A BAD PROCESS
Fix the process before automating it.
Digitalising an inefficient Quality process simply creates an inefficient digital Quality process. Before configuring workflows, we review how the process should operate, which responsibilities are required, what needs to be documented and where approvals or Quality oversight actually add value. Only then do we translate the process into the digital environment.
CONNECT YOUR QUALITY PROCESSES
One system. Connected Quality activities.
Uploading SOPs to a digital platform does not make a QMS digital. The real value comes when the system supports the processes behind the documentation. A document is revised. The right people approve it. Relevant employees are assigned training. Completion is recorded. A change is linked to the document. Associated risks are reviewed. The resulting records remain traceable. That is where digital Quality starts to make a difference.
PLATFORM INDEPENDENT
We build around your needs, not a specific software platform.
Your organisation may already have technology that can support your QMS. Or you may be looking for a dedicated quality solution. OZQA is not built around forcing every customer into the same system. We can work with a platform you already use, help evaluate possible solutions or recommend a system based on your organisation, quality requirements, complexity and budget.
Keep your system
Already have a platform?
We can assess whether your existing technology can support the required quality management processes and help configure the QMS around it.
Choose your own system
Already considering an eQMS?
We can help translate your Quality requirements into system requirements and support implementation of the selected solution.
Let's help you choose
Not sure what you need?
We can help identify an appropriate digital setup based on your organisation, development stage, processes and regulatory requirements.
BUILD DIGITAL FROM THE START
Documentation and digital setup can be built together.
If you are establishing a new Quality Management System, there is no reason to design the documentation first and only later determine how the processes should work digitally.
OZQA can build the QMS architecture, documentation and digital workflows as one implementation project.
Pharmaceuticals
OZQA helps you identify what your organisation needs now, while building with the next milestone in mind.
Starting your QMS journey?
Build the essential quality foundation with our Preclinical Core package.
Ideal for:
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Organisations establishing their first structured QMS before conceptual development
CORE
QMS SOLUTION
Includes
✓ Core QMS documentation package
✓ Customisation to your organisation
✓ eQMS implementation support
✓ 5 hours of QMS training
✓ 14 days of email support after handover
€11,950
Additional consulting support can be added if your organisation requires further customisation or implementation activities.
COMPLETE
QMS SOLUTION
Starting from scratch?
Build a complete clinical Sponsor QMS with OZQA.
Ideal for:
-
For organisations that need to establish the full quality framework for clinical development.
Includes
✓ Core QMS documentation package
✓ Customisation to your organisation
✓ eQMS implementation support
✓ 5 hours of QMS training
✓ 14 days of email support after handover
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:
-
Existing OZQA Preclinical QMS customers
-
Companies with established core quality processes but limited clinical Sponsor procedures
Includes
✓ Core QMS documentation package
✓ Customisation to your organisation
✓ eQMS implementation support
✓ 5 hours of QMS training
✓ 14 days of email support after handover
From €11,950
Additional consulting support can be added if your organisation requires further customisation or implementation activities.
DIGITALISE WHAT YOU ALREADY HAVE
Move from documents and spreadsheets to connected quality.
Many organisations already have a functioning QMS but operate it through a combination of documents, spreadsheets, folders, email and manual follow up. We can review the existing processes, retain what works and translate appropriate Quality activities into structured digital workflows.
AUTOMATE THE ADMINISTRATION
Let the system handle the follow up.
Quality professionals should not have to spend their time manually checking spreadsheets and sending reminders for routine activities. Where appropriate, digital workflows can automate administrative steps and improve visibility.
01. Understand
We review your organisation, Quality processes, regulatory requirements and existing technology.
02. Map
Quality requirements are translated into processes, responsibilities, records and system requirements.
03. Simplify
Existing processes are reviewed before digitalisation to remove unnecessary complexity and duplication.
04. Configure
Workflows, forms, approvals, automations, permissions and relevant system structures are configured.
05. Test & Train
The setup is tested against the intended Quality processes and relevant users are trained.
06. Go Live
The digital QMS is activated and Quality activities move into controlled daily operation.
FROM SOP TO DIGITAL WORKFLOW
We translate Quality requirements into system architecture.
Your SOP may describe what needs to happen. The digital system needs to determine how it happens. OZQA helps translate procedures into practical system elements.
A MORE EFFICIENT APPROACH
Don't pay to rebuild what already works.
OZQA combines your existing Quality system with our established Quality frameworks and ready made documentation. Where your existing processes work, we keep them. Where documentation needs improvement, our existing Quality content can provide a faster starting point than rewriting everything from scratch. This allows consulting time to be focused on gaps, implementation and the areas where expert Quality judgement adds the most value.
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.
Build QMS
Starting from scratch or preparing for your next development stage? Use established frameworks and quality content to get you operational faster.
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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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