Status Management in the Stability Study

Use

All steps performed during the course of a stability study are tracked and documented by the system's status management function. Whenever you perform a process step, the system automatically sets a corresponding user status in the header of the notification to:

Document the action that you have taken
Indicate which process steps you can or cannot perform next

Prerequisites

The standard user statuses for the stability study have been predefined in status profile QM_S_001 in Customizing. This status profile is included in the delivery system, allowing you to implement and use the stability study process, without first having to make any settings in Customizing. You can find this status profile in Customizing for Start of the navigation path Quality Management Next navigation step Stability Study Quality Notification for Stability Study Perform Stability Study Status Management Define Status Profile End of the navigation path .

Features

Overview of User Statuses

The following users statuses have been predefined in status profile QM_S_001 for the standard stability study process:

User Status	Meaning	User Status	Meaning
ACTV	Stability study activated	SCDF	Storage conditions defined
CRIS	Create initial sample	STOR	Stability samples stored
BOMA	Bill of material assigned	CRTS	Create testing schedule
ISCR	Initial sample created	TSCR	Testing schedule created
ISRL	Initial sample released	TSCO	Testing schedule completed
CRIL	Create insp. lot for initial test	STRT	Define start date for stability testing
ILCR	Insp. lot for initial test created	COMP	Stability study completed
COIL	Complete lot for initial test	CANC	Stability study cancelled
DFSC	Define storage conditions	INAC	Stability study inactive

Logical Sequence of User Statuses

The following diagram shows the logical sequence in which the user statutes are typically set during the course of a stability study. Certain user statuses can only be set if a preceding user status has been set (dependence shown by arrows), while other statuses can be set without any dependencies.

Modifying the Standard User Statuses

If you need to modify the status management functions in the standard process to adapt the process to your specific needs, you can:

Create and add additional user statuses in the default status profile QM_S_001
Create your own, new status profile in Customizing and define new user statuses