Compliance & Inspection Readiness
When a regulatory inspection approaches, everything comes down to one question:
Is your quality system ready for review?
At OZQA, we help biotech and life science companies prepare confidently for EMA, FDA, and local GxP inspections.
With our turnkey QMS solution, you gain a fully documented, transparent, and regulatory-compliant system — and the confidence that comes with it.
We make compliance simple
Compliance shouldn’t be a burden. Our practical approach helps you meet all regulatory requirements without getting lost in unnecessary paperwork and complexity.
We focus on what truly matters during an inspection:
Clear definition of roles and responsibilities
Documented procedures and decision-making processes
A QMS that reflects your actual operations
Up-to-date, accessible, and properly signed documentation
Audit readiness from day one
When you implement OZQA’s QMS, your system is designed to be audit- and inspection-ready from the start.
All SOPs, templates, and documents are built on GxP and Good Documentation Practice (GDP) principles, allowing inspectors to clearly see how quality is managed within your organization.
Be inspection-ready without uncertainty
A QMS should be more than a requirement — it should be a practical tool that makes work easier and more efficient.
Our approach is always pragmatic and results-oriented:
Preparation of inspection documentation
Review of procedures and data flow
Mock inspections and audit training
Clarification of GxP roles and responsibilities
Review of deviations, CAPA, and change control
Final review and support before FiH or regulatory inspection
How we ensure compliance
Pre-analysis
We identify gaps or risks in your current QMS.
Customization
The system is updated to meet all regulatory requirements.
Training
Your team learns how to manage inspections and respond to authority questions.
Simulated audit
We can conduct a mock inspection to fine-tune your processes as an add-on service.
Ready for review
You stand with a documented, well-structured, and confident quality system.
Benefits of OZQA’s Implementation Program
Life science expertise
We know what regulators expect
Tailored solution
No unnecessary procedures or templates
Practical approach
We translate requirements into clear, actionable steps
Ready for inspection
Based on EMA, FDA, and ICH-GCP requirements
Ready for inspection and long-term compliance
A robust QMS doesn’t just make your first inspection easier — it builds a sustainable quality culture.
At OZQA, we help you establish a long-term, scalable compliance framework that evolves alongside your organization.