Customer Support

Quality & Regulatory Management

As a global leader in the Life Sciences industry, we are committed to high-quality products and services, manufacturing effectiveness, and meeting our customers’ expectations. Our Quality Vision states: Quality is embedded in everything we do, meaning we provide quality, compliance and business support in the most effective and efficient way for the entire portfolio of our life science business.

              


 Quality & Regulatory Management

An organization that supports you

Quality & Regulatory Management is a core element of our company culture. It is our commitment that our products, processes and services stand for quality. The Life Science Quality & Regulatory Management team supports our  Life Science business to achieve this goal, and to ensure that quality is embedded in everything we do.


 


Our Quality Mission Statement: View online or download PDF

Our Capabilities

Together with Operations, more than 1,700 quality and regulatory professionals ensure compliance and high quality of our Life Science products and services worldwide.

Our Life Science Quality & Regulatory Management team is responsible for identifying and mitigating risks with the support of a risk management system, and ensuring compliance with regulations related to:

  • Chemicals
  • Pharmaceutical and food materials
  • Biologics
  • Medical devices and equipment
  • Animal byproducts.

Our Quality Culture Pyramid

The Life Science Quality Mission Statement is based on our company’s Quality Vision and demonstrates our commitment to quality. As the foundation of our Quality Culture, we have established the Quality Pyramid with its 5 Behavioral Elements and their respective Excellence Criteria.

Quality Culture Pyramid

We foster a quality culture based on:

  • Highly qualified and proactive professionals
  • An environment of customer centricity and continuous improvement
  • Robust and standardized processes
  • Integrated risk management and global tools
  • Measurements aligned with customers’ expectations and regulatory needs

Code of Conduct

Several guidelines are part of our structured system of policies and help us to implement our values and principles. This system aims to ensure that all employees know the relevant rules and regulations, and can apply them to their work. Tried-and-proven management systems ensure that the processes relevant to our Corporate Responsibility strategy are systematically managed and monitored.

Everything we do is based on our 6 company values:

  • Courage opens the door to the future
  • Achievement makes our entrepreneurial success possible
  • Responsibility determines our entrepreneurial actions
  • Respect is the foundation of any partnership
  • Integrity ensures our credibility
  • Transparency makes mutual trust possible


Code of Conduct: Download PDF

Global Citizenship

Our commitment to the community goes beyond our headquarters in Darmstadt, Germany. As an international company, we are involved in the communities that surround our network of more than 100 manufacturing and distribution sites.

Learn more about the variety of projects which our business supports in their local communities.

 Our Quality Management Systems

At the core of maintaining our high quality and regulatory standards is a robust Quality Management System, where all relevant quality and regulatory processes are described. Inspections from authorities, customer and internal audits, customer feedback, along with targeted quality improvement plans provide the input for maintaining these highest standards, as well as for continuously improving our systems, processes and products. This results in an active involvement and ownership of employees across all functions and lives the model that Quality is embedded in everything we do.

Department Overview

The Life Science Quality Management Systems & Audit team works to assess, govern and implement quality processes across our Life Science business with the aim of continuously improving our systems and performance.

The team is responsible for:

  • Continuously gathering information from the experiences of customers using our products
  • Routinely monitoring and reporting these experiences to all levels of management
  • Providing a management system for resolving customer issues or complaints
  • Taking corrective actions when necessary
  • Examining the customer’s information to identify, delineate and report trends
  • Ensuring continuous improvement through self-assessment

Quality Standards

ISO 9001:2015 is the foundation of our Quality Management System for our products and services. Our ISO 9001 Quality Self-Assessment provides in-depth information about our Life Science Quality Management System. The table of content of this document is aligned to « Contents of ISO 9001:2015 Quality Management Systems ». The company profile is aligned to « RX-360 Supplier Assessment Questionnaire, Module 1 ».

Sites that manufacture medical devices are additionally certified to ISO 13485.

To cover higher requirements, we follow additional Quality standards, for example Good Manufacturing Practice (GMP) regulations:

  • U.S. Food and Drug Administration – Code of Federal Regulations Title 21
  • European Medicines Agency – Eudralex Volume 4
  • ICH Quality Guidelines

Overview of our ISO certified Life Science sites and download our ISO certificates

Customer Quality Management: Creating Customer Relationships for Life

Customer Quality Management is an integral part of our commitment to quality and encompasses all manufacturing sites. Our mission is to support our customers by providing accurate and value-added responses to customer concerns and issues in a timely manner. One of the key components of our Customer Quality Management program is addressing customer issues, experiences and complaints.
 

Quality Management Review
Quality Management Reviews are conducted at planned intervals to ensure the continued suitability, adequacy and effectiveness of the Quality Management Systems.
Quality Manual
The Quality Manual describes the basic requirements for implementation, maintenance, and improvement of our Quality Management Systems at every level of our organization. The implementation of the Quality Manual ensures the ability to consistently provide products and services that meet or exceed customer, statutory and regulatory requirements.
Quality Documents Control
For the management of all Quality Documents ManGo (based on CARA) is our electronic system. Besides using ManGo as storage for all GxP relevant documents it also enables thorough management over the entire document lifecycle such as draft, approved, effective and obsolete. A versioning history is available for all documents and notifications are sent in real time in case of periodic review and other tasks. Through a smart interface to our Learning Management System, latest approved documents are made available to the employees instantly.
Data Integrity
Data integrity is fundamental to our Quality Management System which ensures the products released are of the required quality. Data integrity is considered a best practice and is applied to all facets of the business.
Training
Training is conducted to ensure the qualification and the competencies of all employees to current and future responsibilities. Training is conducted by qualified individuals on a continuing basis.
TrackWise System
We relies on the worldwide leading enterprise quality management solution TrackWise to utilize all core business processes, such as Complaint, Change, Deviation and Audit/CAPA management. By implementing TrackWise already in 2008 we have built up one fully validated and centralized database for all Quality Processes. Clear roles and responsibilities in streamline workflows optimize efficiency in the daily management of all quality aspects and guarantee full transparency of all current and past events.
Risk Management and
Continuous Improvement
Quality Risk Management is consistent with the process outlined in ICH Q9. Risk management is based on scientific knowledge. Continuous improvement is accomplished through the process of collection, monitoring and analysis of quality performance indicators, and is focused on product quality, regulatory compliance, customer satisfaction, resource allocation and subcontractor/supplier management.
Audits
Corporate audits, Internal audits and self-inspections are regularly performed across the company and our Life Science business to verify compliance with external and internal standards and procedures, identify areas for continuous improvement, and highlight best practices.

 Quality Services – Customer Support

Every manufacturer must ensure their suppliers provide products that are fit for purpose throughout the product lifecycle, from design and development through to supply to the end-user.

Our Quality Services team is responsible for quality-related elements of Customer Inquiries, Customer Communication, and Quality Support for our Customers. These inquiries include Change Notification, Industry Crisis Communication, Quality Agreements, Complaints, and Questionnaires. We partner with our Technical and Customer Services teams to ensure a seamless support network.

Inquiry Services

Our customers have different regulatory environments, applications, and needs for documentation.

Alongside our products, we provide:

  • Certificates of Analysis
  • Certificate of Origin
  • Specification Sheets
  • Safety Data Sheet

Additional support provided by our Quality Services team:

Change Notifications and Quality Agreements

Our Change Notification Commitment (CNC) is a commitment we make to notify a customer based on a pre-determined set of quality markers. Find out more about the advantages of enrolling into a CNC and how to request a CNC and quality agreement.

Change Notification Commitment (CNC) Change Notification Commitments are legally binding and transparent in their obligations. The process of enrolling is quick and easy:
   • Information needed: catalog number, description
     and contact information
   • The CNC turn-around is from a few days to a few
      weeks, according to the number of products
      involved

What are the Advantages of Enrolling into a CNC?    • Customers can guarantee the proper internal
     contacts are notified
   • Process allows customers to receive only the
     required Change Notifications. Customers can
     opt-out from unwanted notifications
   • Customers can have ALL active part numbers
     in the agreement, including those in qualification

How do I ask for Change Notification Commitments and Quality Agreements? Compile a list of your desired products:
   • Catalog numbers
   • Descriptions
Then provide our customer service an internal contact to receive the Notification(s) (Generic e-mail is preferred, or a minimum of two e-mail addresses are requested in case of a bounce-back)

Partner Support

The increasing importance of a company’s supply chain enhances the need for transparency and two-way dialogue with both suppliers and customers. We have processes and procedures in place to ensure the safety of our supply chain, and to ensure that all of our supply chain partners are adhering to the same quality standards for which our company is known.

Find out more about supply chain transparency and overcoming challenges to transition raw materials – Transparency Complexity & Regulatory Pathway (PDF)

Our Quality Services team pushes industry standards forward and adds value to our customers by providing superior quality and regulatory services. We also train authorities on specific aspects of our products and exchange with them on the evolution of current and future regulations.

Additional useful documents about our products:

Product dating information (PDF)
Product origin information (PDF)
Shipping conditions (PDF)