Validation in the life sciences

One of the biggest challenges of an implementation project, especially in a regulated environment, is to document the business processes to be implemented well and easily.

SAP Solution Manager offers the "Solution Documentation" functionality for this purpose. In a delimited project workspace, the structure of the business processes is mapped in a first step.

Subsequently, the information and documents relevant for each process step are maintained. The creation of the project/validation documents takes place directly within SolMan through the use of MS Office technology.

Documents can be linked within SolMan to ensure traceability of requirements. SAP implementation projects in the regulated environment require the creation, review and approval of system and validation documentation as well as the GxP-compliant maintenance of this documentation as part of change management.

For this purpose, Solution Manager provides document management functionality within Solution Documentation.

Test Management:

Testing of the implemented solution is supported in SolMan by the integrated test management functionality. This functionality is used to perform validation tests as part of the implementation project.

For this purpose, a test plan is created in Solution Manager with reference to the implementation project. Once the test plan has been created, a release scheme can be used to control the test process so that tests can only be performed once the test plan has been formally released.

The tester documents the test execution in a test log. After completion of the test, the test log must be released and the status of the test must be changed according to the result to enable evaluation of the test results.

Errors that occur during the test can be sent and processed as a message via Incident Management in SAP Solution Manager.

Change Request Management:

The goal here is to ensure that changes to productive systems are carried out in a controlled and consistent manner. With the Change Request Management functionality included in SAP Solution Manager, changes can be documented in a traceable manner at any time.

Workflow-based processes ensure that changes are consistently implemented, tested and documented.

Support for end users:

The goal of end-user support is to restore normal operations as quickly as possible after unplanned interruptions and to efficiently process user requests.

SAP Solution Manager provides workflow-based processes for incident management and problem management as well as for processing service requests.

Central user management:

SolMan also allows central user administration for all connected SAP systems. This eliminates the need to assign individual authorizations to the systems within the system landscape.

The use of central user maintenance thus enables consistent user maintenance and a quick overview of all user authorizations.

Recommended implementation sequence:

In order to be able to use SolMan for project/validation purposes as early as possible and thus achieve the greatest possible benefit for the project, a phase-oriented implementation approach is recommended.

In a first step, the solution documentation required for the project is implemented and validated so that this functionality is already available at the beginning of the blueprint and can be used in all further implementation phases.

Subsequently, other Solution Manager functions are implemented in the following order: Test Management, Change Management, Central User Management and End User Support.