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M-Clarity™ Program

The development and manufacture of products in the Life Science industry has become progressively more challenging in recent years. Because of the increasing complexity of the processes, regulatory requirements and local standards, it is crucial to understand, assess and manage risks while ensuring business continuity.

Industry-driven regulations require that products of higher criticality or those used in highly-regulated industries, such as pharma or in vitro diagnostics manufacturing, need enhanced supplier quality support.

In this dynamic context, we present the M-Clarity™ Program which defines product Quality Segments and improves product and service transparency throughout our broad Life Science portfolio.*

Brochure  Quality Attributes  Matrix of Notifiable Changes  Explanation of Notifiable Changes  FAQ

THE M-CLARITY™ PROGRAM GUIDES YOU TO:


The Quality Segments of the M-Clarity™ Program provide transparency so that you can choose, with confidence, suitable products that meet your needs with respect to:

  • Compliance with the appropriate quality and regulatory standards
  • Portfolio transparency
  • Change notification service
  • Documentation and support

The M-Clarity™ Program includes the majority of our products. Chemicals and Consumables are classified into 6 Quality Segments from MQ100 to MQ600, Equipment into 4 Quality Segments from EQ1 to EQ4 and Spare Parts into 2 Quality Segments SP1 and SP2.

Each Quality Segment is defined by a set of Quality Attributes and Notifiable Changes.

To learn more about the Quality Attributes and the Notifiable Changes, please click on the appropriate Quality Segment.


Chemicals and Consumables

MQ100 MQ200 MQ300 MQ400 MQ500 MQ600
For non regulated laboratory applications, with no change notification requirements For research, and non regulated
industrial applications, with limited change notification requirements		 For products used in applications requiring enhanced change control and quality agreement For critical products and applications driven by high expectations for manufacturing control and requiring verified For highly regulated applications requiring a validated process control For highly regulated applications under regulatory surveillance
6 attributes 9 attributes 12 attributes 21 attributes 25 attributes 27 attributes
  CNC** CNC** CNC** CNC** CNC**
    Quality
Agreement		 Quality
Agreement		 Quality
Agreement		 Quality
Agreement
      Quality
Declarations		 Quality Declarations Quality Declarations

Equipment and Spare Parts

EQ1 EQ2 EQ3 EQ4 SP1 SP2
  Discriminating Attributes according to Equipment/Spare Part characteristics
6 attributes 10 attributes 12 attributes 14 attributes 3 attributes 6 attributes
    CNC** CNC**   CNC**

*Contract manufacturing products are not part of the M-Clarity™ Program.
**CNC Change Notification Commitment

For more information on the M-Clarity™ Program, please contact your local representative.