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M-Clarity™ Program, your guide for quality and portfolio transparency

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.*

The M-Clarity™ program guides you to:

M-Clarity™ Program

Select the right product to meet your needs

The M-Clarity ™ Program includes the majority of our Life Science products. Chemicals and consumables are classified into 6 quality segments (MQ100-MQ600). Equipment is classified into 4 quality segments (EQ1-4) and spare parts into two quality segments (SP1-2):

  • Each segment provides specific documentation and services
  • The segments have increasing attributes to meet your application and regulatory requirements
  • Transparency allows you to select the right product for your needs 
    M-Clarity™ Program

    Developing and manufacturing products is a complex process involving multiple suppliers and raw materials.

    Minimizing disruptions when moving from development to manufacturing requires a clear risk assessment.

    The M-Clarity™ Program provides the perfect tool to guide the process of choosing components and raw materials, allowing for comparison of quality support and documentation, and ultimately minimizing costs and delays.

      M-Clarity™ Program

      Quality Segments provide transparency in the attributes of materials to support your control requirements.

      The decision regarding the most relevant quality profile is driven by your specific need for controlled and verified or validated processes as appropriate.

      Leverage the M-Clarity™ Program to choose the appropriate products to develop your own risk assessment.

        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.

        MQ100

        Application scopeFor non-regulated applications with no change notification requirements
        Discriminating featuresStandard control
        Quality systemsISO 9001
        Quality attributes

        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.

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