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SOP 7: Change Control
SOP 7: Change Control
SOP 7: Change Control

SOP 7: Change Control

€985.00Price
Excluding VAT
This SOP defines the controlled process for evaluating, approving, and implementing changes that could affect product quality, safety, or compliance.
 
It ensures traceability, accountability, and proper documentation of all modifications within your QMS, manufacturing, or clinical operations.
 
The document is pre-filled and 99 % complete, requiring minimal adaptation before approval. It aligns with EMA, ICH, and FDA change-management principles.
 
A structured Change Control process demonstrates operational control and regulatory maturity during inspections.

  • What’s included

    1 SOP: Change Control

    2 log form: Change Control Request.

     


    ✓ Editable Word documents

    ✓ Prewritten GxP quality processes

    ✓ Ready for company specific customisation

    ✓ Designed to integrate with related QMS processes

    ✓ Suitable for paper based or electronic QMS implementation

     

  • Benefits

    • Save weeks of documentation work
       
    • Ensure consistent, GxP-aligned documentation
       
    • Maintain controlled versions and effective dates
       
    • Create traceable documentation and revision history
       
    • Provide a scalable foundation for additional Quality processes

  • Suitable for

    • Pharmaceutical companies building or expanding a QMS
       
    • Early stage and growing regulated companies
       
    • Virtual and highly outsourced companies
       
    • Companies strengthening or standardising an existing Quality process
       
    • Quality teams looking for ready to customise documentation

RELEVANT QUALITY PROCESSES

Need other quality documents?

OZQA provides many regulated documents for pharmaceutical, medical device and other industries that need a compliant QMS. If you can't find the SOP, log form or other quality document on our website - don't hesitate to contact us.

START WHERE YOU ARE

Three ways to build a better QMS.

The OZQA QMS provides ready-to-use quality documents, complete QMS packages designed specifically for regulated companies, and expert quality support. Whether you're starting from scratch, improving an existing system or preparing for your next milestone, we help you focus on what actually matters.

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Ready-to-use quality documents designed for regulated companies. OZQA's editable Word documents are ready for company specific customisation and expandable for later development stages.

DOCUMENTS

Build it yourself

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QMS PACKAGES

Start with the full framework

A functioning QMS requires more than SOPs. The package therefore includes relevant supporting documentation to help put the procedures into practice. The documents are designed to work together as one QMS rather than as isolated templates.

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Growing organisations often need Quality expertise long before they need a full internal Quality department. OZQA solutions gives you flexible access to experienced specialists as your needs change.​​​​

Quality Solutions

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BUILT FOR YOUR NEXT MILESTONE

Wherever you are, we help you move forward.

Quality requirements evolve as products, organisations and regulatory responsibilities develop. What is appropriate before a first clinical trial may no longer be enough at Phase III, just as a MedTech company preparing its first Quality system will have very different needs from one approaching certification or market launch.​​

​OZQA helps you identify what your organisation needs now, while building with the next milestone in mind. Explore the journey for pharmaceuticals to see how Quality systems, documentation, oversight and compliance typically evolve as you move forward.

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Pharmaceuticals
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