Digital Signature For Pharma Industry in SolMan

Digital Signature for
Pharmaceutical Industry in
Solution Manager
Applies to:
SAP Solution Manager 7.0 SP15
Summary
Standard SAP digital signature functionality is not extended for usage in SOLMAN 7.0 ChaRM process. The
standard Action Profiles in ChaRM cannot open a popup window for the author to digitally sign and enter his
comments. This is a requirement for the Food & Drug (pharmaceutical) industry as part of the regulations in
CFR Part 11.
Author: Surya Kiran Seemakurty
Company: Intelligroup Inc
Created on: 1 January 2010
Author Bio
Surya Seemakurty is a SAP consultant with expertise in implementing R/3 & CRM Service
Management. He also has expertise in implementing Solution Manager. Presently he is
working as a Principal Consultant with Intelligroup Inc, US.
SAP COMMUNITY NETWORK SDN - sdn.sap.com | BPX - bpx.sap.com | BOC - boc.sap.com | UAC - uac.sap.com
© 2010 SAP AG 1
Digital Signature for Pharmaceutical Industry in Solution Manager
Table of Contents
Digital Signature Concept ................................................................................................................................... 3
Features .......................................................................................................................................................... 3
Solution Manager Functionalities Using this Concept ........................................................................................ 3
Specific Requirement for a Bio-Pharmaceutical Client ....................................................................................... 4
Solution Approach to the Requirement ............................................................................................................... 4
Objects used/modified..................................................................................................................................... 4
Other Development Details ............................................................................................................................. 4
Configurations ................................................................................................................................................. 5
Related Content .................................................................................................................................................. 6
Disclaimer and Liability Notice ............................................................................................................................ 7
© 2010 SAP AG 2
Digital Signature Concept

A digital signature is an electronic signature that enables users to transmit digital documents and official
signatures without physically signing the document. The digital signature includes information such as the
signer’s first and last names, the time & date at which the document was signed, user id and other technical
information. Digital signature uses cryptographic methods or the creator's authentication computed by a set
of rules & parameters. When a digital signature uses encryption, the signature credentials are transmitted in
an encrypted manner and can be verified by the receiver for authenticity. This makes sure that the contents
of data are only visible to the intended recipient(s) and protects the integrity of the data. Similarly, the author
of the signature cannot refute the authenticity of his or her digital signature.
Today, several SAP applications and components, including SAP Solution Manager, provide the ability to
use this technology.
Features
Digital signature and document encryption can be used in applications to provide document security.
Document encryption is independent of transport protocols and they are secured if they leave the system
(e.g., sending or storing of confidential data).
Completely replace the paper signing of documents and also have a legal binding status (e.g., signing the
paperless contracts).
The specific and unique identification of persons or components (for example, in work flow processes)
Digital Signatures in Forms (Signatures can be used in forms on both the client side and, if implemented by
the application, on the server side. A client-side signature gives the end user the option of signing a
completed form in a signature field.)
Authenticity and integrity of data (for example, saving audit logs)
Solution Manager Functionalities Using this Concept
When creating, uploading, changing or deleting a document under Project Documentation tab for a particular
business process
When using Test Management and Test Note
When locking documents against changes by assigning a status
When a document status needs to be changed & releasing documents
When sending e-mail to the user who should sign
© 2010 SAP AG 3
Specific Requirement for a Bio-Pharmaceutical Client
Predicate rules are U.S. Food and Drug Administration regulations other than 21 CFR Part 11 (Electronic
Records; Electronic Signatures) which pharmaceutical companies are required to follow, and are used to
determine the applicability of 21 CFR Part 11. The change management system (ChaRM) in SOLMAN
should be utilized to approve and track changes for many computer systems, some of which will support
regulated business processes. The change management system (in aggregate, work flow for change
request approval process) will need to meet the requirements of 21 CFR Part 11 as defined below.
The components of an electronic record or pending approval for change management are as follows:
Asset information (unique identifier, human-readable name, qualification status)
Change initiation information (change requestor, date and time of request)
Change information (description of change, planned date of change, system test results, user acceptance
test results)
Change approval information (business unit approval including date and time, IT approval including date and
time)
Solution Approach to the Requirement
Standard SAP digital signature functionality is not extended for usage in SOLMAN 7.0 ChaRM process.
More over the standard BAPI’s, used in actions and conditions of ChaRM action profiles, doesn’t have the
capability of popping up a new screen and satisfy all the CFR requirements for digital signature.
Objects used/modified
BADI - EXEC_METHODCALL_PPF
Method – EXECUTE
The Digital Signature code is written in a very generic way in order to use it anywhere in the workflow.
Standard BAPI EXEC_METHODCALL_PPF was copied to a custom method and used. The code in the
custom processing method, calls a custom defined pop-up screen that is used to sign-in and give the
comments/reason for the action performed.
Each time a user performs an action that uses digital signature, the name, time and the comments will be
updated in the Change Request Log/Overview log.
Comments are mandatory in Digital Signature.
If an action definition under action profiles contains the Custom processing method, then it is mandatory to
put the status parameter in the container of this processing method.
Other Development Details
Updating the text logs based on user ID in Digital Signature.
Made use of cl_hf_helper=>handle_notice & cl_hf_helper=>insert_notice function calls in order to update the
log.
Some functionality that was provided in HF_SET_STATUS was missing.
Analyzed the code in HF_SET_STATUS and introduced the same code in custom processing method.
Exception handling.
© 2010 SAP AG 4
Configurations
o New actions and conditions are created.
o For those actions where digital signature is required the customized processing method is assigned.
o Configured all the action profiles with these new actions.
© 2010 SAP AG 5
Related Content
Solution Manager Expert Online - Configure Digital Signatures in SAP Solution Manager
SAP Help - Digital Signature
SDN Community - SolMan Made Easy - Digital or Electronic Signature
Server-Side and Client-Side Security Functions
© 2010 SAP AG 6
Disclaimer and Liability Notice

This document may discuss sample coding or other information that does not include SAP official interfaces and therefore is not
supported by SAP. Changes made based on this information are not supported and can be overwritten during an upgrade.
SAP will not be held liable for any damages caused by using or misusing the information, code or methods suggested in this document,
and anyone using these methods does so at his/her own risk.
SAP offers no guarantees and assumes no responsibility or liability of any type with respect to the content of this technical article or
code sample, including any liability resulting from incompatibility between the content within this document and the materials and
services offered by SAP. You agree that you will not hold, or seek to hold, SAP responsible or liable with respect to the content of this
document.
© 2010 SAP AG 7

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Digital Signature for

Digital Signature Concept

Solution Manager Functionalities Using this Concept

Specific Requirement for a Bio-Pharmaceutical Client

Solution Approach to the Requirement

Other Development Details

Updating the text logs based on user ID in Digital Signature.

o New actions and conditions are created.

o Configured all the action profiles with these new actions.

Disclaimer and Liability Notice

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