Change Management for Formulas 

Use

Depending on the branch of industry and product, manufacturers in process industries must comply with different legal requirements as regards the planning, documentation, and release of formulas. For this reason, recipe management offers different processing methods allowing different levels of freedom during formula editing and guaranteeing change documentation of a varying extent.

This section provides you with an overview of the processing methods available in formula management and the functions that you can use to evaluate the processing steps performed.

Integration

●     In addition to the processing method, formula editing is also regulated by the scopes of application of a formula and their statuses. Via the status, you release a formula, for example, and protect released formulas against improper changes (see Scope of Application for Formulas).

●     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. Their scopes of application and change states may deviate from those of the recipe to which they are assigned.

○     With dependent formulas, the corresponding recipe determines the editing method, change states, and statuses of the formula (see the documentation of the individual editing methods).

If you have to comply with the requirements of Good Manufacturing Practices (GMP) for the pharmaceutical industry or a similar standard, we recommend you assign dependent formulas to your recipe types and make the use of change master records obligatory. You make these settings in Customizing for Recipe Management in the IMG activity Recipe Settings.

Features

Function	Description
Formula Editing Without Change Master Records	This function enables you to freely create and change formulas on a key date. However, you do not get a change history in the form of different change states.
Formula Editing with Change Master Records	This function enables specially authorized users to plan, create, and document changes in a detailed manner. You obtain a change history in the form of defined change states.
Evaluating the Use of Change Master Records	You use this function to evaluate how change master records are used in recipes, formulas, and their scopes of application. You obtain an overview of the change states and scopes of application created using a particular change master record.

Recipe management only supports change master records with date validity but not with parameter effectivity.