Audits & Remediation - Quality Assurance - QbD group

QA 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 QA audits & remediation?

QA 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 QA audits important?

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

Ensure compliance and stay informed: regular audits align with authority expectations and evolving regulations.
Improve processes within resource limits: identify inefficiencies and enable action, even across dispersed teams.
Anticipate and manage risks: spot issues early like supplier changes to avoid disruptions.
Enhance site communication: strengthen engagement with local teams for smoother execution.
Show commitment under pressure: maintain quality and compliance despite operational challenges.

Discover how we can support you

Specialized expertise

Benefit from deep regulatory know-how in niche areas to ensure compliance and reduce risks.

Flexible resourcing

Scale teams up or down quickly to match project needs and avoid costly delays.

Unbiased & cost-efficient

Gain objective insights while saving on internal audit resources and infrastructure.

Round-the-clock operations

Leverage global time zones to keep projects moving and accelerate timelines.

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Why QbD Group?

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

Expertise across GxPs: seasoned lead auditors for GMP, MD/IVD, PV, and clinical audits, ensuring the right fit every time.
Global audits, EU-trained base: 50–100 audits yearly across key regions, backed by EU-trained and local experts.
End-to-end coordination: a dedicated coordinator manages planning, execution, and reporting - no surprises.
Scalable audit network: in-house experts and global freelancers ready for peaks or specialized needs.
Clear planning and budgeting: full visibility from kickoff to reporting, with no hidden costs.
Effective communication: aligned, consistent contact with your team and audit sites throughout.
Flexible tools and support: ready to adapt to changes and complex, multi-site audits with expert systems.

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.

QA Audits & Remediation

What are QA audits & remediation?

Why are QA audits important?

How can we help?

Specialized expertise

Specialized expertise

Flexible resourcing

Flexible resourcing

Unbiased & cost-efficient

Unbiased & cost-efficient

Round-the-clock operations

Round-the-clock operations

Why QbD Group?

Our process

1. Preparation

2. Audit execution

3. Reporting

4. Follow-up

Get in touch