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QMS Setup Quality Assurance - QbD Group (3)

QMS Setup

Ensure compliance and efficiency with tailored Quality Management Systems
 
Do you need help implementing a compliant Quality Management System for your life sciences organization? At QbD Group, we provide QA experts experienced in creating smart, effective, and compliant QMS solutions tailored to your needs. Whether your focus is GMP, GCP, GDP, or ISO standards, we ensure your system drives business value and regulatory compliance.
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What is a QMS?

A Quality Management System (QMS) is a structured framework of processes and procedures designed to ensure the quality, safety, and effectiveness of products in the life sciences sector. At QbD Group, we support organizations in implementing QMS solutions that align with their size, scope, and complexity. Key aspects of a QMS Setup:

  • Regulatory compliance: Ensure conformity with applicable laws and standards, including ISO 13485:2016, 21 CFR 820, EU Regulations 2017/745 & 746, and MDSAP.

  • Tailored solutions: Processes adapted to your organization’s specific activities and goals.

  • Documentation: Development of all required procedures, policies, and manuals.

  • Stakeholder training: Educating teams to adopt and maintain QMS standards effectively.

  • Continuous improvement: Embedding practices that drive efficiency and reduce waste.

Discover why a decent QMS setup is essential

QMS Setup Quality Assurance - QbD Group (1)

Why is a QMS important?

Implementing a QMS is not only mandatory for regulatory compliance but also brings significant business benefits:

  • Mandatory for certification: No QMS, no product certification or market access.

  • Operational consistency: Standardized processes lead to fewer errors and inefficiencies.

  • Continuous improvement: A QMS fosters an environment of ongoing optimization.

  • Enhanced decision-making: Evidence-based processes enable better business decisions.

  • Customer satisfaction: Improved product quality translates to higher patient and customer trust.

 

Discover how we can support you

How can we help?

QbD Group offers flexible and comprehensive QMS Setup services to meet your unique needs:

Full-service QMS implementation

Full-service QMS implementation

  • Workshops to define requirements and processes.

  • Creation of all necessary documentation.

  • Training of stakeholders and publication of QMS.

Coaching and support

Coaching and support

  • Workshops introducing requirements.

  • Review and refinement of your organization’s documentation.

Startup assistance

Startup assistance

Introductory workshops to guide your team in understanding and planning for QMS implementation.

QMS Setup Quality Assurance - QbD Group (4)

Why QbD Group?

When you partner with QbD Group for QMS Setup, you benefit from:

  • Proven expertise: Decades of experience in quality assurance and regulatory compliance.

  • Tailored approaches: Solutions adapted to your organization’s size, complexity, and goals.

  • Compliance by design: Procedures built to integrate seamlessly with your current workflows.

  • Cross-disciplinary knowledge: Expertise in QA, RA, validation, and more.

  • Scalable solutions: Services designed to grow with your organization.

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Our process

1. Assessment

We analyze your current processes and identify gaps.

2. Workshops

We work with your stakeholders to understand requirements and design solutions.

3. Documentation development

We create tailored procedures, policies, and manuals that meet regulatory standards.

4. Training and implementation

We equip your team with the skills to adopt, implement, and maintain the QMS.

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Ready to implement a smart, compliant Quality Management System?

QbD Group helps life sciences organizations build tailored QMS solutions that ensure regulatory compliance and drive business value. Contact us today to learn more.

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