Question 1

What does OZQA offer?

Accepted Answer

OZQA provides turnkey Quality Management Systems (QMS), ready-to-use SOP templates, and implementation services for biotech, pharma, and life science companies.
 We help organizations simplify GxP compliance and achieve inspection readiness faster.

Question 2

Do we need to have a quality team in place before we start?

Accepted Answer

No, not necessarily. OZQA also supports early-stage companies that may not yet have a full quality function in-house. Our SOPs are simple to apply and tailored for lean teams or solo founders.

Question 3

How long does implementation takes?

Accepted Answer

Implementation typically takes 3–6 weeks, depending on the scope and number of documents.
 We design every project to reach inspection readiness as efficiently as possible.

Question 4

Will the SOPs be adapted to our specific company setup?

Accepted Answer

Yes. The SOPs come with editable action lists and templates, allowing you to tailor them to your company's operations while remaining fully compliant.

Question 5

Will this prepare us for an inspection?

Accepted Answer

Absolutely. The system is built to help you demonstrate a functioning QMS during an inspection. We help you ensure everything is signed, implemented, and ready for review.

Question 6

What is included in the SOP templates?

Accepted Answer

Each SOP template is pre-filled, written by QA professionals, and aligned with EMA, FDA, and ICH GxP guidelines.
Templates include standardized sections such as purpose, scope, responsibilities, procedure, and references — all in editable Word format.

Question 7

Can templates be customized to our company?

Accepted Answer

Yes. All templates are fully editable and can be tailored to your internal processes, terminology, and roles.
If you need help adapting them, our Service Packages include guided implementation and support.

Question 8

What is the difference between Basic and Premium packages?

Accepted Answer

The Basic Package focuses on QMS implementation — setting up your documentation, structure, and control.
The Premium Package adds training sessions and assistance to help your team maintain compliance independently.

Question 9

What is a full QMS implementation?

Accepted Answer

Our Full QMS Solution includes all SOPs, log forms, system setup, training, and support — ready for EMA/FDA inspection.
It’s a complete, turnkey system tailored to your organization.

Question 10

Can we purchase individual SOPs or log forms?

Accepted Answer

Absolutely. You can buy single SOPs or log forms directly from our template catalog.
 Each document can be downloaded immediately and later integrated into a larger QMS setup.

Question 11

Are OZQA templates compliant with GxP and regulatory requirements?

Accepted Answer

Yes — all documents are aligned with GxP, ICH, EMA, and FDA expectations for documentation and quality systems.
They’re designed to pass audits and inspections without additional rewriting.

Question 12

Who develops the templates and QMS systems?

Accepted Answer

All documentation is developed by QA professionals with real experience from biotech, clinical, and pharmaceutical companies.
Our team has supported both early-phase and commercial-stage organizations through audits and regulatory submissions.

Question 13

Do you provide digital QMS integrations?

Accepted Answer

Yes. Through our Premium Service Packages and Full QMS solution, we include support for SOP editing, training modules, and document optimization.
We can also help integrate your documentation into electronic QMS platforms.

Question 14

Do you work internationally?

Accepted Answer

Yes. OZQA serves clients across Europe, USA and worldwide.
All templates and systems are designed according to internationally recognized GxP standards and can be adapted to regional requirements.

Question 15

How can we get started?

Accepted Answer

You can start by:
1. Purchasing templates (https://www.ozqa.dk/category/all-products)directly through our webshop, or
2. Contacting (https://www.ozqa.dk/contact)us to discuss your QMS needs.

Consulting

Practical Quality, Compliance & Pharmacovigilance Support for Life Science Companies. OZQA provides practical consulting support within quality management, regulatory compliance, and pharmacovigilance for pharmaceutical and medical device companies.

GxP, Pharmacovigilance & ISO Quality Support

Areas of Consulting Support

How We Work

OZQA consulting is intended to support specific quality and compliance needs, not to replace internal ownership of quality or PV systems:

Is your QMS inspection-ready?

FAQ