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Outsourced QA - Quality Assurance - QbD Group

Outsourced QA

Simplify Quality Management with Tailored Outsourced QA Services

Do you need to kickstart your QMS or ensure ongoing compliance without operational headaches? At QbD Group, we take over your quality assurance activities with a dedicated team of experts. From supplier management to deviation handling, we provide seamless, cost-effective solutions so you can focus on your core strategy.

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What is outsourced QA?

Outsourced QA involves delegating your quality management system (QMS) activities to a team of professionals experienced in life sciences regulations. Whether you need support for the entire system or specific quality functions, we provide scalable and flexible solutions to meet your organization’s needs. Key aspects of Outsourced QA:

  • Full or partial outsourcing: Tailored solutions ranging from complete QMS management to support for specific quality functions.

  • Remote or hybrid delivery: Services offered remotely or in a hybrid model for flexibility.

  • Expert guidance: Access to industry professionals skilled in supplier management, complaints, deviations, and more.

  • Seamless operations: We integrate with your processes to ensure smooth and compliant quality activities.

  • Scalability: Adjust services to match your changing workload and business needs.

Discover why outsourced QA is important

Outsourced QA Quality Assurance - QbD Group (1)

Why is Outsourced QA important?

Consistency and compliance in quality assurance are critical to maintaining product supply and regulatory approval. Outsourcing QA helps you:

  • Ensure compliance: Stay aligned with evolving life sciences regulations.

  • Reduce operational costs: Eliminate the need for in-house expertise.

  • Access specialized knowledge: Benefit from experts familiar with your product and production types.

  • Focus on core competencies: Free up internal resources to drive innovation.

  • Mitigate risks: Maintain audit readiness and reduce compliance errors.

 

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How can we help?

QbD Group offers tailored outsourced QA services to fit your unique challenges and goals:

Full system outsourcing

Full system outsourcing

  • We manage your entire QMS, from documentation to training.
  • Ensure seamless compliance and operational consistency.

Partial outsourcing

Partial outsourcing

  • Delegate specific functions such as audits, batch reviews, or supplier management.
  • Retain production-specific knowledge in-house while outsourcing quality activities.

Peak-based outsourcing

Peak-based outsourcing

  • Engage experts to handle overflow situations, such as compliance remediation or system upgrades.

  • Scale resources up or down based on your workload needs.

Outsourced QA Quality Assurance - QbD Group

Why QbD Group?

When you choose QbD Group for Outsourced QA, you gain:

  • Top-notch expertise: Access to industry-leading knowledge in life sciences quality management systems.

  • Proven experience: A strong track record of success with leading organizations.

  • Tailored solutions: Flexible approaches designed to meet your specific needs.

  • Global reach: Remote and hybrid models available in multiple languages.

  • Reliable results: A commitment to precision, timeliness, and compliance.

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Our process

1. Assessment

We evaluate your current procedures and define the scope of outsourcing.

2. Service level agreements

Establish clear deliverables, timelines, and performance metrics.

3. Implementation and execution

Integrate the outsourcing team and initiate QMS activities.

4. Monitoring and optimization

Continuously evaluate performance and optimize processes for improvement.

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Ready to simplify your quality assurance processes?

QbD Group provides flexible Outsourced QA solutions tailored to your needs. Whether you require full system management or targeted support, our experts are here to help. Contact us today to learn more.

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Why should we outsource our quality management system?

Outsourcing helps you access specialized expertise, ensuring compliance without the overhead of managing it in-house. It allows you to focus on your core business while experts handle the complexities of quality management.

How can outsourcing improve compliance?

Outsourcing ensures that your quality system is managed by professionals who are up-to-date with ever-changing regulations. It reduces the risk of compliance errors and ensures your processes are always audit-ready.

How do you know that we and by extension our consultants are reliable?

We carefully train and maintain the experience, certifications, and track record of our consultants. You’ll have transparency throughout the process, with regular updates and performance reviews.

Can outsourcing help reduce costs?

Yes, outsourcing eliminates the need for long-term hires and overhead costs, offering a more cost-effective solution. It allows you to pay for services as needed, without sacrificing quality.

What types of quality management services can be outsourced?

You can outsource a range of services including audits, training, regulatory submissions, documentation management, batch review, supplier management, and more. This allows you to tailor the outsourcing solution to fit your needs.

How quickly can outsourcing be implemented?

The timeline depends on your needs, but we work efficiently to integrate outsourcing with minimal disruption. Typically, we can have things up and running within a month.

Will we lose control over our quality processes?

Not at all! You’ll remain in control, with the flexibility to set expectations and monitor progress. Outsourcing complements your operations, providing expert support without losing oversight.