Audits & Remediation

Ensure compliance and continuous improvement with expert auditing services

Do you need help implementing your annual audit plan or resolving findings from past audits? At QbD Group, we offer certified and experienced auditors to perform internal and supplier audits on your behalf. Our QA experts can also support you in resolving audit findings effectively, ensuring compliance and driving improvement.

What are audits & remediation?

Audits are a critical component of any Quality Management System (QMS). Internal audits and self-inspections ensure the performance and compliance of your organization, while supplier audits are essential for qualification and monitoring. QbD Group provides auditing services tailored to your specific needs, delivering detailed reports and actionable insights. Key aspects of our auditing services:

Internal audits: Comprehensive assessments to ensure your QMS meets regulatory standards.
Supplier audits: Qualification and monitoring of suppliers to ensure compliance and reliability.
Customized programs: Management of your entire audit plan, including individual audit reports and overall summaries.
Detailed reporting: Clear findings, non-conformities, and recommendations for corrective and preventive actions.
Follow-up support: Optional review of action plans to address audit findings

Discover why audits are essential

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Why are audits important?

Audits are not just a regulatory requirement; they are opportunities for growth and improvement. Here’s why they matter:

Regulatory compliance: Meet expectations from authorities and certification bodies for regular audits.
Process optimization: Identify gaps or inefficiencies and develop corrective actions.
Risk mitigation: Reduce risks by proactively addressing non-conformities.
Continuous improvement: Use audits to refine and enhance your QMS.
Credibility: Demonstrate a commitment to quality and compliance to stakeholders.

Discover how we can support you

Internal audits

Ensure your organization’s processes meet QMS standards.

Supplier audits

Assess and monitor suppliers to meet regulatory and operational requirements.

Comprehensive audit programs

Let us manage your full audit program, including planning, execution, and reporting.

Follow-up support

Address audit findings with expert guidance for corrective and preventive actions.

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Why QbD Group?

When you choose QbD Group for auditing services, you benefit from:

Unbiased perspective: Gain objective insights from external experts.
Specialized expertise: Access auditors with extensive experience in life sciences.
Resource optimization: Save time and resources by outsourcing audits to professionals.
Scalable solutions: Flexible support to handle peak workloads or complex programs.
Proven experience: Over 70 audits performed annually for clients worldwide.
Global reach: Auditing expertise spanning Europe and beyond, including Turkey and China.

1. Preparation

We begin with an initial consultation to define the audit objectives, scope, and criteria. This ensures that expectations are clear and aligned. At least one week before the audit, we share an agenda outlining the timeline and confirming whether the audit will take place on-site or remotely.

2. Audit execution

During the audit, our auditors thoroughly assess your procedures, records, and key personnel. Observations are documented in detail, and non-conformities are identified alongside actionable recommendations to address any gaps.

3. Reporting

After the audit, we deliver a comprehensive report that provides a full overview of the audit findings. This includes identified non-conformities, areas for improvement, and tailored recommendations to enhance compliance.

4. Follow-up

If requested, we assist with reviewing and commenting on corrective action plans to confirm their effectiveness and ensure that the proposed actions address the findings appropriately.

Audits & Remediation

What are audits & remediation?

Why are audits important?

How can we help?

Internal audits

Internal audits

Supplier audits

Supplier audits

Comprehensive audit programs

Comprehensive audit programs

Follow-up support

Follow-up support

Why QbD Group?

Our process

1. Preparation

2. Audit execution

3. Reporting

4. Follow-up

Get in touch