The Complete QMS Template Package from OZQA provides a fully written, inspection-ready documentation system designed specifically for biotech and life science companies in preclinical development and Phase I–II clinical trials.
 
The package includes all 13 core SOPs required to operate a compliant Quality Management System (QMS), as well as all supporting log forms needed to document training, deviations, CAPAs, change control, vendor oversight, complaint handling, and regulatory updates.
 
Every document in the package is professionally written, pre-filled, and 90–99% complete, requiring only minimal customization such as your company name and QA approver.
They are aligned with GxP, ICH, EMA, and FDA expectations and developed by QA experts with real inspection experience.
 
This complete QMS package allows startup and early-phase biotech organizations to build a compliant, scalable and inspection-ready quality system within days instead of months — without relying on expensive consulting hours.
 
What’s included
 
13 Fully Written SOPs
Covering essential quality processes such as:
Quality Manual
SOP System
Organization & Training
Vendor Selection & Sponsor Oversight
Risk Evaluation & Management
Archiving
Recall
Product Complaints
Pharmacovigilance
Monitoring of New Regulations
Change Control
CAPA
Serious Breach
Each SOP is structured, ready to approve, and written using industry-standard GxP language.
 
All Required Log Forms (Under-SOPs)
Including:
Training records
Signature/initial lists
Deviation logs
Change control logs
CAPA logs
Supplier approval and tracking forms
Recall documentation
Complaint investigation logs
Regulatory update tracking
Serious breach assessment logs
… and more.
 
Every log form is fully formatted, pre-filled and ready for immediate use.
 
Designed for Early-Phase Biotech
 
This package is tailored for companies who:
Are operating in preclinical, Phase I or Phase II
Outsource activities to CROs, CMOs, laboratories and consultants
Need a complete QMS framework that meets regulatory expectations
Want to demonstrate quality maturity to investors, partners, and authorities
Need documentation that supports inspection readiness
 
Whether you are preparing for your first clinical trial, establishing sponsor oversight, or building the foundation for GMP operations, this package gives you everything you need to put a compliant QMS in place quickly and confidently.
 
Benefits
Save 3–6 months of documentation work
Achieve inspection readiness rapidly
Avoid costly consultant hours
Ensure consistent, GxP-aligned documentation
Build investor confidence with a robust QMS
Scale smoothly into Phase III and commercialization
 
All documents are editable Word files, ready for integration into your QMS or electronic QMS platform.
 
Who is this package for?
Ideal for:
Early-stage biotech companies
Virtual biotech and companies with outsourced operations
Preclinical research teams moving toward Phase I
Phase I/II sponsors preparing for audits and inspections
Lean QA teams requiring a complete documentation framework