SOP Document Packages
Our templates follow a clear, audit-proven structure with consistent terminology, roles, and responsibilities. If you need a complete QMS package, we deliver documentation that’s ready to use and easy to adapt.
Ready-to-use SOPs developed according to GxP standards
Our documentation package covers the key areas within GMP, GCP, GLP, and GDP.
Each SOP and Log Form is written based on regulatory requirements but structured practically, making it easy to understand and apply in daily operations.​
Choose what you need or get the complete package
Our documentation suite includes both SOPs (Standard Operating Procedures) and Log Forms.
All templates are editable and can be customized to your organization’s processes.
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Each OZQA template is developed from real regulatory experience. Not just theory. We combine GxP best practices with clear documentation language, so your team can focus on running compliant operations instead of writing SOPs from scratch.
A structure built to withstand inspection
All documents are developed in compliance with Good Documentation Practice (GDP) and support a structured, audit-ready document management system.
This ensures that you can present your system confidently to inspectors, with clear documentation of how quality is managed and maintained in your organization.
Built by QA experts. Trusted by biotech professionals.
SOP templates
Professionally structured procedures covering all core quality processes.
Each SOP is pre-filled, GxP-compliant, and aligned with biotech Phase I–II operations.​
Examples:
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Document Control SOP
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CAPA SOP
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Change Control SOP
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Supplier Qualification SOP
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Archiving SOP
(and more...)
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Key benefits:
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Based on GxP and ICH guidelines
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Fully editable in Word format
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Developed by QA professionals with audit experience
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Aligned with EMA and FDA expectations
Log form templates
Maintain traceability and ensure compliant recordkeeping with standardized, easy-to-use log forms.
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Examples:
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CAPA Log
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Training Record Log
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Deviation Log
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Change Control Log
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Equipment Maintenance Log
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Key benefits:
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Ready-to-use structure for data capture
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Designed for traceability and compliance
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Editable format (Word or Excel)
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Compatible with both manual and digital QMS
Other templates
Expand your documentation with specialized templates designed for advanced quality operations.
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Examples:
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QP–QP Agreement (Qualified Person to Qualified Person)
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Quality Agreement (Sponsor–CRO/CMO)
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Supplier Qualification Pack
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Key benefits:
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Fully GxP-aligned formats
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Ready-to-use and editable
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Ideal for outsourced or multi-site operations
Complete package
Includes all SOPs and log forms — pre-filled, GxP-aligned, and ready for implementation.
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Includes:
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All validated SOPs
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All log forms and registers
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Document structure and numbering system
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Quality Manual and templates for records
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Key benefits:
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Full inspection readiness in one package
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Consistent structure and traceability
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Saves months of documentation work
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Used by QA professionals in active biotech environments
A SOP system that grows with you
OZQA provides professionally written SOP templates and log forms for biotech, pharma, and life science companies.
Each document follows EMA, FDA, and ICH GxP requirements and includes consistent formatting, version control, and responsibility definitions.
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Our SOP templates cover all major quality processes including document control, CAPA, training, change control, supplier management, and deviations.
Log forms ensure traceability and compliance across your operational activities.
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With OZQA templates, you can implement a professional, audit-ready quality management system in days instead of months.
Combine individual documents or select the complete QMS template package for a full documentation suite.