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QMS Remediation & Support Quality Assurance - QbD Group

QMS Remediation & Support

Keep your Quality Management System compliant and effective

Do you need help addressing issues identified during an inspection or audit? Are you looking for support to resolve self-identified gaps in your QMS or to maintain smooth operations?

Labmark offers QA experts experienced in managing and upgrading Quality Management Systems (QMS) to ensure continuous compliance and operational excellence.

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What is QMS remediation & support?

Implementing a QMS is only the first step; maintaining and improving it is an ongoing process. Labmark’s QMS Remediation and Support services provide expert guidance to keep your QMS operational, compliant, and continuously improving. Whether you need remediation for gaps identified in audits or inspections or require support for daily QMS activities, we tailor our services to your organization’s specific needs. Key aspects of QMS Remediation and Support:

  • Operational support: Assistance with managing and maintaining QMS activities.

  • Gap remediation: Identifying and resolving deficiencies following audits, inspections, or self-assessments.

  • Continuous improvement: Ensuring your QMS evolves with updated regulations and best practices.

  • Documentation management: Supporting your team to "write what you do and do what you write."

  • Compliance assurance: Helping you achieve and sustain certification.

Discover why QMS remediation and support are essential

QMS Remediation & Support Quality Assurance - QbD Group (1)

Why is QMS remediation and support important?

Maintaining an effective QMS is essential for regulatory compliance and operational success. Here’s why it matters:

  • Regulatory updates: Regulations evolve, and your QMS must adapt to remain compliant.

  • Inspection readiness: Proper documentation and processes ensure your QMS can withstand audits and inspections.

  • Operational consistency: Standardized processes reduce errors and ensure smooth operations.

  • Continuous improvement: Ongoing monitoring and analysis help identify gaps early and address them proactively.

  • Risk mitigation: Early detection and resolution of issues prevent costly non-compliance penalties.

 

Discover how we can support you

 

How can we help?

Labmark offers flexible QMS Remediation and Support services tailored to your organization’s unique needs. Here’s how we work with you:

Remediation support

Remediation support

  • Address gaps identified in inspections, such as 483s, Warning Letters, or audit findings.

  • Implement corrective and preventive actions (CAPA) to ensure compliance.

Operational QMS support

Operational QMS support

  • Provide day-to-day management of QMS activities, including risk assessments and documentation.
  • Support ongoing monitoring, analysis, and effectiveness checks.

Tailored expertise

Tailored expertise

  • Assign experienced QA professionals to support your team on-site or remotely.

  • Offer scalable solutions, from junior to senior-level expertise.

QMS Remediation & Support Quality Assurance - QbD Group (2)

Why Labmark?

When you partner with Labmark for QMS Remediation and Support, you benefit from:

  • Extensive expertise: Over 150 experts with experience across small and large organizations, various product types, and multiple languages.

  • Regulatory knowledge: Numerous interactions with competent authorities ensure compliance at every level.

  • Tailored solutions: Flexible support designed to meet your organization’s unique challenges.

  • Proven success: A track record of ensuring compliance and operational excellence for global clients.

  • Global reach: On-site and remote support available to suit your needs.

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Our process

1. Assessment

We evaluate your QMS and identify gaps or areas for improvement.

2. Customized action plan

We develop a plan tailored to your needs and regulatory requirements.

3. Implementation

Our experts assist with remediation, operational support, and documentation.

4. Continuous monitoring

We ensure your QMS remains compliant and effective through regular updates and evaluations.