trenzyme’s High Quality Standards

We set great value upon high quality standards and transparency. Our dedicated quality management combined with a research and laboratory information management system (LIMS) ensures continuous documentation, traceability, transparency and highest quality standards. trenzyme’s quality system and compliance are subject to regular audits and inspections by regulatory authorities.

DIN EN ISO 9001:2015
High Quality Standards at trenzyme GmbH

trenzyme’s High Quality Standards

Our quality management system, certified to DIN EN ISO 9001 since 2009, in combination with a research and laboratory information management system (LIMS), ensures continuous documentation, traceability, transparency and thus the highest quality standards for our products. trenzyme’s quality system and compliance are subject to regular audits and inspections by regulatory authorities and clients.

Learn More About Our High Quality Standards

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Logo TÜV ISO 9001

trenzyme is committed to highest quality standards and complete transparency and has been DIN EN ISO 9001 certified since 2009. The certification of our quality management system covers all areas – from customer service and ordering to production processes and product delivery – and is subject to a continuous improvement process. This process is supported by regular audits and inspections by regulatory authorities and clients.

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Our QMS together with a research and laboratory information management system (RALIMS developed by AAC Infotray AG and fully implemented since 2011) combines the advantages of LIMS and ELN (Electronic Laboratory Journal) systems. It ensures complete documentation, traceability and transparency and enables production processes to deliver even GMP and DIN EN ISO 13485 compliant products.

Our Quality Management System

  • DIN EN ISO 9001 certified QMS since 2009
  • Quality management manual including policy on EHS (environmental, health and safety)
  • Quality policy and objectives defined
  • Continuous improvement process implemented
  • Change control
  • Knowledge management
  • Risk management

Relevant Standards and Guidelines

  • Certification: DIN EN ISO 9001
  • Partial implementation: DIN EN ISO13485, DIN EN ISO27001, DIN EN ISO14001
  • GMP compliance: according all required national and international current standards

Administration Of Our Management System

  • Limsophy BPM (Business Process Management) for versioned administration of the QMS
  • LIMS (Laboratory Integrated Management System) with full audit trail for process documentation, product identification and traceability

Data Protection and Information Security

  • IT-Guideline fully implemented since 2019 to ensure information security and access controls
  • Compliance with GDPR: supervision by external data protection officer (MachCon GmbH), concept for data retention and deletion and procedure directory in place, technical and organisational measures implemented

Sustainability

  • In order to contribute to environmental and climate protection, it is our policy that every colleague takes responsibility for making our processes more sustainable.
  • We are committed to ensuring that every employee takes responsibility for making the processes we use more sustainable, so that the environment and climate are protected.

Our Quality Standards

  • Internal Audit / Self-Inspection program
  • Personnel / Training program
  • Operations system control / Access restriction
  • Materials control system / Warehouse
  • Supplier evaluation
  • Equipment control
  • Production / Process control
  • Product release procedure / Labelling system
  • Non-Conformance Reportin

Custom Options Available

  • Detailed information regarding our controls and programs on request
  • Documentation, quality agreements and supply agreements according to your individual requirements

What Our Clients Say About Us

It was a pleasure to work with trenzyme. Our expectations were fully met. trenzyme’s team of professional scientific experts helped us to complete our objectives in time. We were also pleased with the quality of the documentation provided. In a nutshell, I can recommend trenzyme as a reliable service provider.

Michael Samassa Celonic AG, Basel, Switzerland
clients logo celonic trenzyme

Your Benefits From Working With Us

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Expertise

Since 2000, our highly qualified scientific experts employ their extensive experience to complete your project successfully and efficiently.

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Customization

Our modular service packages are custom-tailored to your project and allow high flexibility. All services run under ISO9001 quality management standards.

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Communication

We design project-specific solutions and your project manager keeps you constantly informed throughout the project to ensure maximum success.

christina haenisch project manager trenzyme
Christina Haenisch, PhD
Project & Quality Manager

Christina is happy to help you as your personal contact regarding project & quality management.

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