Function documentationDigital Signature in QM

 

The SAP system provides the digital signature tool to sign and approve digital data. The digital signature ensures that certain tasks are only performed by specially authorized users and documented in a signed document together with the name of the signatory and the date and time.

You need the digital signature to comply with the GMP guidelines (Good Manufacturing Practices) for the approval and documentation of quality-related processes.

The Quality Management (QM) component uses both individual signatures and signature strategies:

  • With individual signatures, a document is signed and approved by the signature of one authorized person.

  • With signature strategies, the single signatures of different user groups are merged into one signature process. This means that signatures are required from more than one person for approval.

You can use digital signatures in the following functions:

  • In the inspection lot: During results recording

  • In the inspection lot: Usage decision

  • When confirming the physical-sample drawing, that is, when releasing the first physical sample of a physical-sample drawing

  • For notifications

Integration

In the SAP system, the digital signature is supported by the Basis component Secure Store and Forward (SSF). This provides you with various signature methods. If you use the user signature as the signature method, you require an external security product that is linked to your SAP system using SSF.

For more information about digital signatures, see Approval Using Digital Signatures.

Prerequisites

The following prerequisites must be fulfilled for a user to be able to use a digital signature in the functions listed above:

  • You have made the general settings for digital signatures (see Approval Using Digital Signatures).

  • You have activated the digital signature for Quality Management. This means:

    • You have defined the need for a digital signature in QM-Material Authorization for inspection processing (see Customizing for Quality Management under Start of the navigation path Environment Next navigation step Central Functions Next navigation step Authorization Management Next navigation step Define Authorization Groups and Digital Signature End of the navigation path).

    • You have entered the QM material authorization for the relevant material in the Quality Management view of the material master.

    • For physical-sample drawings, you have also set the indicator that requires the digital signature to be confirmed (see SAP Easy Access menu Start of the navigation path Logistics Next navigation step Quality Management Next navigation step Quality Planning Next navigation step Basic Data Next navigation step Sample Next navigation step Sample-Drawing Procedure End of the navigation path).

    • For notifications, you have specified the digital signature for each notification type and each business transaction (see Customizing for Quality Management under Start of the navigation path Quality Notifications Next navigation step Notification Processing Next navigation step Digital Signature Next navigation step Specify Digital Signature End of the navigation path).

    • If necessary, you have specified different signature remarks for each step of the signature process (see Customizing for Quality Management under Start of the navigation path Environment Next navigation step Central Functions Next navigation step Signature Strategy Next navigation step Define Signature Remarks End of the navigation path).

Note Note

An individual signature is only possible for results recording, usage decisions, and confirmation of physical-sample drawing.

To use this, in Customizing for Quality Management under Start of the navigation path Environment Next navigation step Central Functions Next navigation step Authorization Management End of the navigation path execute the activity Define Authorization Groups and Digital Signature. On the Material Authorization Group, Inspection Lot Approval, Digital Signature detail screen, do not select the new digital signature strategy.

End of the note.

Features

You can use the digital signature for the following functions in Quality Management:

  • Individual signature

  • Signature strategy

  • Synchronous signature process

  • Asynchronous signature process

  • Signatory can be changed

  • Comment required

  • Application-specific reason for signature (comment)

  • Predefined signature remarks

Special Features When Using Results Recording

In the results recording area, you can use a worklist to select all inspection lots that have open or completed signature processes. To do this, select Start of the navigation path Quality Management Next navigation step Quality Inspection Next navigation step Worklist Next navigation step Inspection Next navigation step Signature Process End of the navigation path.

When you print the results, you can also print the digital signature.

When you have completed results recording, you can display all changes to the digital signature using Start of the navigation path Extras Next navigation step Change History End of the navigation path.

Special Features When Using Usage Decisions

When using usage decisions, all characteristics that have not yet been processed for the inspection lot are displayed on the characteristics tab. You can use All Characteristics to switch to the view that shows all characteristics, including those that have been completed properly. Here you can use the digital signature icon to display the signature steps that have been executed.

Physical samples are displayed on a separate tab. When you double-click on one of the samples, you branch to results recording where you can display the digital signature.

When you have made the usage decision, you can display the signatory by choosing Start of the navigation path Extras Next navigation step Digital Signature End of the navigation path.

Special Features When Using Notifications

For notifications, the digital signature depends on the notification type and the business transaction. The digital signature is possible at the following levels:

  • Header level

    The digital signature cannot be executed until the notification has a number.

  • Task level

  • Action box

    When you create an activity, the signature process is started automatically. For example, when you create a repair order, you can execute the digital signature immediately and then save the notification. If you selected a signature strategy and you call up the notification again, you must complete the signature process without making any changes to the notification. Otherwise, the signature process must be started again.

You can display changes to the digital signature when the signature process is completed by choosing Start of the navigation path Extras Next navigation step Notification Documents Next navigation step Digital Signature End of the navigation path.