Complete QMS package: Phase I & II

The Complete QMS SOP 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 12 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.
 
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.
 
All documents are editable Word files, ready for integration into your QMS or electronic QMS platform.
 
The Phase I/II Complete package includes 13 fully written SOPs and 12 log forms :
 
Quality Manual
An updated Quality Manual reflecting the expanded scope, responsibilities and quality processes associated with clinical development.
 
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.
 
Recall SOP
Defines how potential all investigational medicinal products (IMP) recalls are assessed, coordinated, documented and escalated when required.
 
Product Complaints SOP
Complaint investigation form
Establishes a controlled process for receiving, assessing, investigating and documenting IMP product quality complaints.
 
Safety Reporting SOP
Defines responsibilities and processes for safety information and reporting during clinical development, including oversight of relevant outsourced activities.
 
Monitoring New Regulations SOP
Regulatory update tracking
Establishes a systematic approach for identifying, assessing and implementing relevant changes to regulations, guidelines and regulatory expectations.
 
Change Control SOP
Change control requests
Change Control Numbering
Provides a structured process for assessing, approving, implementing and documenting changes that may affect quality, compliance or clinical activities.
 
CAPA SOP
CAPA form
Defines how quality issues are investigated and how corrective and preventive actions are identified, implemented, followed up and documented.
 
Serious Breach SOP
Serious breach assessment form
Establishes the process for identifying, assessing, escalating and reporting potential serious breaches related to clinical trials.