Formula Editing with Change Master Records

Use

You use change master recordsto centrally plan, manage, and document related changes to different objects, for example, changes to recipes, formulas, and their scopes of application. Note that the creation and use of the change master record is linked to a special authorization. You obtain a change history in the form of defined change states. Used together with status management, you establish a transparent creation and release process.

See also:

Integration

Depending on the type of formula assignment in the recipe, bear in mind the following when editing formulas (see Formula Assignment ):

  • You can freely choose the editing method for independent formulas, that is, you can decide whether you edit a formula with or without the use of a change master record. You can thus edit these formulas with any change master record intended for formulas.

  • For dependent formulas, the relevant recipe determines the editing methods and the change states. The following applies:

    • You can only choose the editing method that is prescribed for the recipe type. You specify the editing method, that is, whether the use of a change master record is prohibited, optional, or obligatory, for each recipe type in Customizing for Recipe Management in the IMG activity Recipe Settings .

    • You edit the formula with the change master record that is assigned to the change state of the recipe loaded. Only if no change master record has been assigned to the change state, can you edit the formula without using a change master record. The system uses the valid-from date of the recipe as the key date.

      Recommendation Recommendation

      If you have to comply with the requirements of Good Manufacturing Practices (GMP) for the pharmaceutical industry or a similar standard, we recommend you make the use of dependent formulas and change master records for your recipe types obligatory.

      End of the recommendation.

Prerequisites

  • To prevent changes being made with change master records whose valid-from date is in the past, we recommend you activate the date check in Customizing for Engineering Change Management in the IMG activity Set Up Control Data .

  • You created a change master record with the following attributes and data in engineering change management:

    • Date validity

      Formulas do not support change master records with parameter effectivity.

    • The valid-from date required for the change

    • If required, the authorization group of the users to which you want to restrict the change master record usage

    • A status that permits object changes

    • The object types PVS Variant and Substance (specification)

      For more information about change master records, see the Engineering Change Management component under Change Master Record .

Features

Formulas consist of several change objects (for example, formula header, material items, and substance items) whose change states may deviate from each other. Note the following when editing formulas with a change number:

  • When you create a formula, the system creates all edited objects on the valid-from date of the change master record.

  • When you change an existing formula, the system creates a new change state with the valid-from date of the change master record for all edited objects. The validity period of the existing change state ends with the day immediately before. Each change you make to a formula object is thus also documented in the formula header.

  • When you display a formula, the system displays the change state that is valid on the valid-from date of the change master record for each object.

  • By shifting the valid-from date of a change master record, you can change the validity of the objects edited with it (such as formula, recipe, scopes of application, and so on). The system adjusts both the valid-from date of the relevant change state and the valid-to date of the preceding change state. The date can only be adjusted if the date change is allowed in all objects affected. Note the following restrictions for formulas:

    • You cannot shift the valid-from date of a change state to a date before the valid-from date of the preceding change state or a date after the valid-from date of the succeeding change state.

    • In dependent formulas, you cannot shift the valid-from date of a change state to a date before the current date.

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Activities

  • When you create or edit a formula in formula editing, you enter the change master record in the initial screen of the recipe workbench. It is identified by a change number (see Specifying Key Dates and Change Numbers ).

  • You shift the valid-from date of a change state by changing the valid-from date of the relevant change master record in engineering change management.