Every Marken employee is responsible for quality from our drivers to our CEO, and we have developed a robust quality management system that is ISO 9001:2015 certified to ensure our services meet the highest standards.
All of our facilities worldwide are compliant with Good Manufacturing Practices (GMP) for Clinical Supply Center-related activities or Good Distribution Practices (GDP) for logistics activities to meet all regulatory and industry standards around the world.
The quality standards we follow include:
- FDA Regulations, including cGMP and 21 CFR Part 11
- EMA GMP Regulations
- EU GDP Regulations
- ISO Standards
Marken’s Quality Management System (QMS)
Marken’s Quality Management System (QMS) has been designed to be effective, efficient and sustainable. Our structure is based on the classical pharmaceutical industry model and is ISO 9001:2015 certified. It starts with a Global Quality Manual and Quality policy at Level 1. Level 2 consists of the global standards, which then trickles the requirements to Level 3 SOPs (Standard Operating Procedures), work instructions and processes.
Document hierarchy at Marken also includes various guidance documents. In addition to GMP elements, the entire system is designed with input from GDP guidelines, and specific regulatory requirements from the various countries where Marken offers services.
It is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It helps coordinate and direct Marken’s activities to meet customer and organizational / regulatory requirements and improve its effectiveness and efficiency on a continuous basis. Our QMS:
- Sets best-in-class bar for clinical logistics
- Speaks the language of our Pharma clients
- States our Mission, Quality Objectives, Core Values, Vision, Commitment
- Formalizes how we perform our work
- How we document & measure what we have done
Our Quality Manual provides an overall overview of Marken’s Quality Management System, describes what is included and how the components are applied to Marken’s processes. Our Quality Policy expresses Marken’s commitment to quality and associated governance, additional policies and addresses specific needs.
Marken’s compliant, simple and accessible IT platform ZenQMS offers:
- Permission based access/privileges
- Google-like search across all data and attached files
- Full document lifecycle management from draft to retirement
- Enforcable document approval workflows by category
- Secure exports, including watermarked PDF
- Ability to create and distribute drafts for collaboration
- Allows the export of data to create various metrics reports for all levels in the organization
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.