Equipment Qualification

Flexible and customized solutions for equipment qualification

Are you looking for a turnkey solution for the C&Q and Equipment Qualification part of your project? Whether you are building or renovating and need to qualify your equipment, we are here to help! From simple to more complex equipment and systems, QbD Group offers flexible and customized solutions to meet your needs.

What is equipment qualification?

Equipment qualification is the process of ensuring that machinery, instruments, or systems used in production, laboratory testing, or any other processes consistently perform as intended.

It includes documented activities to prove that equipment operates within a set of pre-defined specifications and delivers reliable results. This process is critical for ensuring compliance with industry standards and maintaining product quality and operational consistency.

Annual Product Review (APR) & Product Quality Review (PQR) QbD group

Why is equipment qualification important?

Equipment qualification is an essential step in ensuring regulatory compliance, operational efficiency, and product quality. Here’s why it matters:

Regulatory compliance: Ensures alignment with industry standards and regulatory requirements, reducing the risk of non-compliance.
Reliable performance: Confirms that equipment consistently delivers accurate and repeatable results.
Risk mitigation: Identifies and resolves potential issues before production begins, minimizing downtime and failures.
Product quality assurance: Guarantees that processes meet quality standards, safeguarding final product integrity.
Operational efficiency: Optimizes processes by ensuring equipment operates at peak performance.

Discover our process

Our process

QbD Group provides flexible and scalable equipment qualification services tailored to meet your project requirements. Whether you need a turnkey solution, where QbD manages the entire project from planning and execution to documentation, or a hybrid approach, where your company oversees project management while QbD handles the qualification process, we offer the expertise and adaptability to support your needs.

Step 1: Planning and design

We begin with an in-depth analysis of your needs, developing User Requirement Specifications (URS) and defining clear design criteria. A traceability matrix is built to track requirements throughout the process.

Step 2: Commissioning and qualification

We build and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols. Our team ensures compliance with specifications and documents all results.

Step 3: Performance qualification

We define Performance Qualification (PQ) scenarios, create protocols, and execute tests on the work floor to verify equipment performance under real-world conditions.

Step 4: Final reporting and validation

A comprehensive report is generated, summarizing results, findings, and any necessary corrective actions. The process concludes with documented validation to meet regulatory standards.

Why choose QbD Group?

When you partner with QbD Group, you benefit from:

Expert project management: Clear and pragmatic direction to ensure timely and compliant execution.
Cost efficiency: Reduce overall costs through effective project management and risk mitigation.
Regulatory expertise: Ensure compliance with all regulatory standards, minimizing risk and delays.
Scalable solutions: Flexible approaches to match your project scope and requirements.
Right-first-time approach: Pragmatism and efficiency are part of our DNA, ensuring your project is delivered correctly the first time.

Get in touch

Ready to ensure your equipment meets the highest standards for performance and compliance?

QbD Group provides expert equipment qualification services to help you validate systems, enhance performance, and ensure compliance. Contact us today to learn more.

Resources

Case study

Scalable MSAT validation support for seamless compliance & efficiency

Discover how QbD Group helped a global pharmaceutical company address fluctuating validation demands across multiple teams.

Case study

Guiding a global biotech company through ATMP facility qualification

Discover how QbD Group supported a global biotech company in commissioning and qualifying two ATMP therapy production sites, ensuring compliance and efficiency.

Whitepaper

Achieving laboratory compliance

This whitepaper explores the multifaceted aspects of laboratory compliance, including data integrity, quality control measures, and regulatory adherence.

Whitepaper

New GMP Facility Qualification: set-up, process and best practices

This whitepaper delves into the challenges of establishing a new GMP facility, focusing on potential pitfalls and best practices. Download now.

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