Quality

At Marken, we’re passionate about our Quality System. That’s why it’s at the core of everything we do. Marken’s culture of quality is instilled in all team members, from our drivers to our senior management. It’s all about establishing the highest GDP/GMP/GCP standards to ensure we always find a way to deliver for you.

Marken’s robust eQMS system ensures that our services and facilities set the highest standards in the industry. A customized global set of processes drives every step of our logistics activities to meet all regulatory standards around the world. From storing and moving APIs, biological samples, medical devices, genetic material and special agents – to manufacturing kits, re-labeling products and handling sensitive patient data, we set the best-in-class bar for clinical logistics. We utilize key tactical metrics with leading indicators to achieve Six Sigma levels.

All Marken facilities globally are compliant with Good Manufacturing Practices (GMP) for Clinical Supply Center-related activities and Good Distribution Practices (GDP) for all logistics activities and supply chain solutions.

Marken’s Culture of Quality

  • Our employees live quality in all their actions
  • Building quality into our personalized services
  • Understanding our client’s challenges and pain points
  • Emphasis on client satisfaction

 

Marken’s Quality Objectives

  • Meet all customer and regulatory requirements to the fullest extent
  • Strive for error-free and consistent execution
  • Protect patient safety and confidentiality, and clinical trial material integrity

 

A Quality System Just Like Our Pharma Clients 
Marken’s Quality Management System (QMS) has been designed to be effective, efficient and sustainable. We speak the pharma language and have based our quality structure on the classical pharmaceutical industry model, which is ISO 9001:2015 certified.

  • Compliance with GMP/GCP/ISO and CSV-Part 11
  • Independent-empowered quality unit
  • Warehouse, facility and material controls
  • Quality audits and supplier management
  • GMP investigations, CAPA policies
  • Document life cycle and control
  • Trainings with role-based curricula
  • Change control system

 

The Value Our Quality Brings to You

  • Enhance reputation and ensure patient safety
  • Avoid loss of revenue
  • Build trust
  • Create efficiency
  • Increase client satisfaction

 

Marken’s Unique Quality Differentiators 

1. Quality Manual includes GDP Compliance

2. Marken GDP Program and Certifications

3. Operational Excellence Program

4. eQMS

5. Cross Functional Quality Council

6. Weekly EC Management Quality Review

7. Role Based Curriculum

 

Certification Programs for All LSP Levels

 

Talk to a dedicated Marken expert at marken.com/contact.

 

 

 

MARKEN’S GOLD BOOK

Marken’s Gold Standard for GDP Compliance

The Gold Standard book outlines Marken’s dedication to the storage and transportation of drug products and, the company’s leading role in developing an extensive certification program. The guide emphasizes the critical nature of GDP compliance for the life science supply chain industry and offers details on guidelines, compliance and the impact on industry and clients.

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