Implement and validate SAP S/4HANA with VITAL

Life Sciences Alliance

SAP S/4HANA implementation and validation

Life Sciences Alliance Project Method

For the implementation and validation of SAP S/4HANA in Life Sciences, LSA has developed the procedure VITAL. VITAL stands for integrated implementation and validation in regulated industries, such as the pharmaceutical industry and medical technology.

The implementation and validation of SAP S/4HANA are not separated from each other in terms of organization and methodology in order to avoid extra work, inconsistencies and errors! In the following, our approach is described in its main features. A modern approach to the implementation and validation of SAP S/4HANA includes elements of agile project methods such as SCRUM. In a regulated environment, the validation of the IT system is required, which is performed according to the industry standard GAMP®5. This standard suggests the use of the V-model. For the implementation of optimal workflows, the use of business process management approaches in combination with a preconfigured solution architecture, based on the Intelligent Enterprise philosophy, has proven to be effective. The methodology combines the different approaches to a harmonized, consistent and cost-optimized procedure, which is specifically tailored to the requirements of the life sciences industry. The project approach and methodology of the SAP S/4 implementation have a significant influence on the successful course of the project and the associated costs and efforts.

The basic understanding of SAP implementation is always based on the approach: Standardization before individualization! This is a must for system implementation, especially with regard to ensuring release compatibility in the application and the outlook for the increasing digitization of business processes as well as openness to new business models.

Customization should only be used where the company’s USP depends on it and a unique selling proposition is absolutely essential for business success.

Appropriate solution components are available to accelerate implementation.

The VITAL Solution Components​

The Digital Process Landscape (DPL) contains all processes of the digital core relevant in the value chain as well as industry-specific solutions from the SAP Ecosystem and has been continuously developed in an evolutionary manner over the last 25 years. Two goals are pursued in the process,

  • Use of the business content to create the user requirements/user story and the resulting functional specifications, and
  • Creation of a redundancy-free and harmonized structure for the GxP-compliant operation of SAP S/4HANA.
  • Strong reduction of implementation time due to our preconfigured solution
  • Large selection of industry-specific processes and functions for medical technology and the pharmaceutical industry
  • Easy adaptation of the solution to your company and organizational structure, also through a predefined role and authorization model
  • High project and operational stability through pre-tested and audited industry standards
  • By applying industry best and right practices, you improve the cross-process integration understanding in your company
  • Increased usability through new user experience (SAP Fiori)
  • Availability for different operating models (S/4HANA on Premise and RISE with SAP, Private Cloud Edition)

The IT Compliance Framework was developed to ensure the implementation, validation and GxP-compliant operation of SAP S/4HANA from day one. It contains best-practice validation processes, SOPs and templates that are optimally tailored to SAP projects with the goal of secure implementation and operation of the system. This is particularly important when planning, hosting, operating and supporting in the cloud or outsourcing to a service provider, e.g. Life Sciences Alliance. When using the IT Compliance Framework, timely re-validation of the SAP system in case of changes is guaranteed (Managed Validation Services).

Processes and SOPs are consistent and logically aligned, ensuring efficient and cost-effective operation throughout the entire lifecycle.

  • All mandatory activities and functions of the CSV are defined in the framework.
  • Oriented to the GAMP®5 V-Model and GAMP®5 Operation GxP Systems.
  • Focus on systems to support business processes

This provides the standard requirements for SAP S/4HANA and sample documentation.

Best practice requirements at:

  • Business process level
  • Detail process level
  • Consistent documentation example

To ensure efficient validation processes in the project - but above all also in the operation of the SAP system - LSA provides a cloud-based validation platform via which validation documents and SOPs are digitally managed and controlled. In addition, SAP Solution Manager is used on the one hand to provide the preconfigured and documented solution and on the other hand to control the IT processes (incident and change management) in support. This enables the digital implementation of the IT processes described in the IT Compliance Framework for the efficient operation of an SAP system in the life sciences.

  • Part 11-compliant electronic signatures
  • Status of validation documents in dashboards
  • Automation and digitalization of validation processes easily implemented
  • SaaS solution - ready to use
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