Preclinical Core QMS Package

Build the quality foundation your company needs before clinical development.
 
The OZQA Preclinical Core QMS is designed for early stage biotech and pharmaceutical companies that want to establish structured quality processes before entering clinical development.
 
Instead of building a QMS from a blank page, you receive a carefully selected set of fully written, ready-to-customise quality documents covering the core processes your organisation should have in place as it grows.
 
The result is a practical QMS foundation that works for your organisation today and can be expanded as your development programme progresses.
 
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.
 
This package gives you everything you need to put a compliant preclinical QMS in place quickly and confidently.
 
All documents are editable Word files, ready for integration into your QMS or electronic QMS platform.
 
Your Preclinical Core QMS includes 6 fully written SOPs and 6 log forms:
 
Quality Manual
Defines the overall structure, scope, responsibilities and principles of your Quality Management System.
 
Document Manangement
Establishes how controlled documents are created, reviewed, approved, revised, distributed and archived.
 
Training and Organisation SOP
Documentation for Training records
Annual Training Program Log
Signature/initial lists
List of Resigned Employees
Defines organisational responsibilities and ensures personnel are appropriately qualified and trained for their assigned activities.
 
Vendor Management SOP
Evaluation and Approval of Vendors
List of Outsourced Activities
Provides a structured approach to selecting, qualifying, monitoring and overseeing external vendors and service providers.
 
Risk Management SOP
Establishes a consistent, risk based approach for identifying, evaluating, controlling and reviewing quality risks.
 
Archiving SOP
Defines requirements for secure retention, retrieval, protection and disposal of quality records and documentation.