Recipe Editing With Change Master Records 

Use

You can use change master records to plan, manage, and document related changes to different objects (for example, recipe, formula and their scopes of application) centrally. Note that the creation and use of the change master record is linked to a special authorization. Changes you make in the recipe are logged in change documents. In addition, you obtain a change history in the form of defined change states. Used together with status management, you establish a completely transparent creation and release process.

See also:

●     Formula Editing with Change Master Records

●     Scope of Application

Prerequisites

●     Using change master records is allowed for your recipe types (see Customizing for Recipes, IMG activity Recipe Settings).

If you have to comply with the requirements of Good Manufacturing Practices (GMP) for the pharmaceutical industry or a similar standard, we strongly recommend specifying this editing method as mandatory.

●     To prevent changes being made with change master records whose valid-from date is in the past, we recommend switching on the date check in engineering change management (see Customizing for Engineering Change Management, IMG activity Set Up Control Data).

●     A change master record with the following attributes and data has been created in engineering change management:

○     Date validity. Recipe management does not support change master records with parameter effectivity.

○     The valid-from date required for the change state

○     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

○     Object types PVS variant for recipe editing and, in addition, Substance (specification) for formula editing. In recipes with dependent formulas, you also need the object type Substance for recipe editing.

For information about creating and editing change master records, see the documentation of Engineering Change Management under Change Master Record.

If you have the required authorization, you can also create or generate change master records from within recipe editing while creating change states. To use generation, the appropriate change number profile must have been assigned to the recipe type (see Customizing for Recipes, IMG activity Recipe Settings).

Features

Note the following when editing recipes with change master records:

●     You can use change numbers to create a new recipe or another change state for an existing recipe. You obtain exactly one change state for each change number. You specify the valid-from date, which may not be before the current date, centrally in the change master records. It applies to all objects that have been edited with the change master record. The validity period of the preceding change state ends with the day immediately before.

●     When you load a recipe with a change number, the change state that was created with the change number is loaded. Changes apply to this change state.

●     By shifting the valid-from date of a change master record, you change the validity of the objects edited with this change master record. Both the valid-from date of the relevant change state and the valid-to date of the preceding change state are adjusted. The date can only be adjusted if the date change is allowed in all objects affected. Note the following restrictions for recipes:

○     The valid-from date of a change state cannot be changed to a date before the current date. It cannot be before the valid-from date of the preceding change state or after the valid-from date of the succeeding change state.

○     If status management has been activated for a recipe, you can only shift the valid-from date of a change state if it has system status In process. If you want to shift the date into the future, the preceding change state must have status In process or Rejected.

See also:

●     Validity of Recipes: Example

●     Documentation of Engineering Change Management, Date Shift for the Valid-From Date

Activities

●     You enter the change master record with which you create or edit a recipe on the initial screen for recipe editing. It is identified by a change number (see First Steps in Recipe Editing).

●     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.