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Modeling Specifications

Goals

  • Know what Specifications are and when to use them.

  • Know how to configure new Spec Types.

  • Know how to create new Specifications.

What are Specifications?

Specifications are important metrics associated with the Batch. These numeric fields must be assigned a Spec Type and have a min and/or max value.

Common Spec Types include:

  • CPP – Critical Process Parameter

  • CQA – Critical Quality Attribute

  • KPP – Key Performance Parameter

  • KPI – Key Performance Indicator

  • NCPP – Non-Critical Process Parameter

  • NKPP – Non-Key Process Parameter

How does an End User use Specifications?

The Specifications tab displays information about the Spec Plan assigned to the Batch.

mes_specifications_tab_3_3.png

The Specifications summary table includes,

  • Step – the Sub-Step that contains the field.

  • Spec Type – the defined spec type for the field.

  • Description – the name of the field.

  • UOM – the unit of measure defined for the field.

  • Min – the defined minimum.

  • Max – the defined maximum.

  • Actual Value – if the field has been entered, the value that was entered.

  • Status – an indication of whether the actual value met the limits defined by the minimum and maximum. This column displays a warning icon only if the actual value was out of range.

  • Comment – any comments that were entered for the field.

How to configure new Spec Types

Before Spec Types can be assigned to a numeric field, they must first be defined in L7 Configuration.

config_spec_types_3_3.png

To configure a new Spec Type:

  1. Go to L7 Configuration.

  2. Select the esp Configuration.

  3. Switch to "code view".

  4. Add the new Spec Type to lims → field_spec_types.

  5. Save the Configuration.

How to create new Specifications

Go to: L7|Master → Protocols → select an existing Protocol or + New Protocol

master_specification_field_3_3.png

To create a new Specification:

  1. Select + Add Field.

  2. Select Numbers only allowed as the Type.

  3. Expand the Parameters.

  4. Select the desired Spec Type from the picklist.

  5. Set the desired parameters (min and/or max is required)

    Note

    Values for numeric fields in L7 MES cannot be formatted, but they can be displayed to a specified number of decimal places (significant figures are not supported in L7 MES).

    Precision only impacts the displayed value. The underlying value is not changed.

    The min and max are soft limits in L7 MES, meaning the user can enter a value outside of this range.

    All out of range values will appear as exceptions in the Quality Review tab.

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