User Requirements Specification (URS)

Main Process

 

Defines precisely and clearly what the user expects the system to do. The document contains information about the operating environment, the required data for processing, and the functionality that the system should carry out. Additionally, the URS can contain non-process-related topics, such as processing time requirements, cost, etc.

In a regulated environment, the URS should have a reference on the GxP regulation and must interpret it.

Is a platform that provides the integrated content, tools, and methodologies that you need to implement, support, operate, and monitor your enterprise's solutions in the pharmaceutical industry from SAP. These include:

• URS documents are the descriptions of the functionalities that the customer wants to run in the system. These documents can be managed with SAP Solution Manager.
• The roadmap of SAP Solution Manager supports the fully documentation of the different phases of the project, including predefined accelerators with versioning and status management.
• The business blueprint phase of SAP Solution Manager allows the management and documentation of all kinds of templates, documents, etc. with versioning, status management, and definition of electronic signatures.
• The platform integrates content, tools and methods for implementation, support, operation, and control;

enables central administration and control of allocated, decentralized applications; and provides automatic functions for evaluation of problems

Represents prepackaged business expertise in the form of methodology, documentation, and reliable preconfiguration for SAP Business Suite solutions for pharmaceutical industry. All the experience from SAP and its partners are encapsulated in this package.

SAP Best Practices for Pharmaceuticals contains two packages:

• Documentation CD includes business documentation, technical documentation, documentation templates, and conversion forms. This is also available as a download and online on SAP Service Marketplace.
• System Add-On CD contains all the necessary elements that are needed for the installation process of SAP Best Practices. This is also available as a download.

In order to support customers and partners to achieve the full potential of SAP Business Suite solutions, the ValueSAP tools like AcceleratedSAP and GlobalSAP, are transitioning to SAP Solution Manager. SAP Solution Manager is the portal for implementation and operation and continuous business improvement for SAP Business Suite. Consequently, it is the platform for the entire project team.

• It includes a combination of tools, methods, and content for the optimization of SAP projects. This includes a proven roadmap supporting the solution concept, process-oriented configuration, and tests as well as tools for an effective SAP implementation.
• Global ASAP is an implementation method focusing on ASAP concepts.
• Global ASAP supports template and rollout projects that include several sites, products, and systems.

Includes planned and systematic reviews of developments, specifications, and the design throughout the life cycle. In the design reviews, the deliverables are evaluated against the standards and requirements described in ISO 9001:2000.

The design reviews should be done for the technical, the solution, and also for the project design.

According to the FDA, each manufacturer should establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the design development.

Customers installing new automated systems should understand and manage the risks in conjunction with the benefits. During an implementation of a new system, several risk assessments should be conducted.

It is not practical to test every aspect of an automated system, but by conducting the risk assessment the focus for the critical areas can be detected. The following steps include a risk assessment:

• Step 1: Planning the risk assessment
• Step 2: Performing the risk assessment
• Step 3: Reviewing the risk assessment document(s)
• Step 4: Issuing the risk assessment

Continuous change management ensures an ongoing validated status in the regulated production. Change control management (CCM) is the required tool for the change management in the SAP and non-SAP environment. Change requests are directly connected and integrated in Business Configuration Sets (BC-Sets) for documentation of customizing settings. Additionally, transport orders can be assigned.

For further information, contact the market development department of the industry sector chemicals and pharmaceuticals or contact the production unit for chemicals/pharmaceuticals in SAP Consulting.