SAP S/4HANA Validation

Computer-aided systems, such as SAP S/4HANA, play a central role today both in the pharmaceutical industry and in medical technology. If such a system is used in quality-relevant or GxP-critical business areas, the company must provide documented proof within the framework of a software validation that the system functions according to predefined specifications and also fulfils these in everyday operation.

With SAP S/4HANA, SAP launched a new generation of its ERP software in 2016, which is intended to make companies fit for the challenges and opportunities of the digital future. But what does this new technology mean for companies in a regulated environment that have to operate and validate the system according to the applicable laws and guidelines (e.g.: EU GMP, FDA, ISO 13485:2016)?

What are the implications of the choice of transformation strategy (new implementation vs. system conversion)?
What do the new ERP operating models (cloud, on-premise, hybrid) mean for SAP S/4HANA validation?
Is the use of SAP S/4HANA Cloud an option in the regulated environment?
How does the SAP Activate project methodology align with your validation methodology?
How to deal with increasing mobilisation and the use of Fiori Apps?

Since 1996, we have been supporting companies in the life sciences industry (pharma, medical technology and biotechnology) worldwide with the implementation and validation of their SAP systems as industry experts. Thanks to our expertise in the areas of business processes, SAP and IT compliance, we are now the leading consultancy in the German-speaking region for the validation of SAP systems.

The DHC approach for software validation of SAP S/4HANA is based on standards from the ISPE GAMP Guidelines. It is process- and risk-based with the aim of reducing costs and testing and documentation efforts by directing the validation focus to the critical aspects of the processes and the system. The requirements of different regulations (e.g. FDA CFRs, EU-GMP Annex 11) and standards (e.g. ISO 13485) are taken into account.

The method has proven itself in the project as well as in operation, and it is supported equally by the business department and IT. The procedure model is part of the DHC Best Practice Method and also consists of work instructions (SOPs), templates, training documents and tools for the validation of SAP systems. It covers the complete system life cycle from initial implementation, through the operational phase, to decommissioning and data archiving. Appropriate accelerators are available to speed up the validation process.

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,

Using the technical content to create the user requirements/user story and the resulting functional specifications and
Creation of a redundancy-free and harmonised structure for the GxP-compliant operation of SAP S/4HANA.

The IT Compliance Framework is designed to ensure the implementation, validation and GxP-compliant operation of SAP S/4HANA from day one. It containsbest-practice validation processes, SOPs and templates that are optimally tailored to SAP projects with the aim 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. When using the IT Compliance Framework, the timely re-validation of the SAP system in case of changes is guaranteed (Managed Validation Services).

Processes and SOPs are consistent and logically coordinated and ensure efficient and cost-efficient operation over the entire life cycle.

All mandatory activities and functions of the CSV are defined in the framework.
Orientates itself 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 example documentation.

Best practice requirements on:
- Business process level
- Detail process level
Pervasive documentation example

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

To ensure efficient validation processes in the project – but especially also in the operation of the SAP system – DHC provides a cloud-based validation platform through which validation documents as well as SOPs are digitally managed and controlled. SAP Solution Manager is used to provide the pre-configured and documented solution and 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 digitisation of validation processes easily implemented
SaaS solution – ready to use

Compliance Check & Strategy

The complexity of SAP products has increased continuously in recent years. In addition to the digital core SAP S/4HANA, a digital toolbox has emerged that supports the departments with specialised applications (e.g. Success Factors, Ariba) as required. In addition, different deployment options (on premise, private cloud, public cloud) are increasingly leading to hybrid system structures. This increasing variability must be taken into account accordingly in the validation. In addition, new technologies such as machine learning or artificial intelligence require a rethink of traditional validation approaches.

Our consultants will gladly and competently support you in the following topics:

Fit gap or inspection readiness analysis of your validation framework as well as your SAP validation documentation (Friendly Audits / Compliance Checks)

21 CFR Part 11 & EU GMP Annex 11 Assessments
Data integrity assessment
Development of remediation plans, e.g. adapting your risk-based validation strategy to new regulatory requirements
Conceptualisation of a validation strategy tailored to SAP systems and respective deployment option, taking into account the SAP Activate project methodology
Construction of a paperless validation platform based on the SAP Solution Manager incl. efficient IT service management processes
Software validation / IT compliance workshops
Development of test strategies
Development of data migration and verification strategies
Coaching of QA / validation managers

Validation Services

The core of our Validation Services is the risk-based and economic execution of the validation of your SAP systems. We are also happy to provide you with our DHC best practice method here. We offer the following implementation services:

IT infrastructure qualification: This forms the foundation for SAP validation. We ensure that your IT infrastructure components are qualified in line with the audit.
Building a cloud compliance framework for using SAP S/4HANA as a private cloud edition.
Prospective SAP validation: SAP systems and the business processes mapped onto them are validated during implementation.
Retrospective SAP validation: SAP systems in productive use and the business processes mapped onto them are validated during ongoing operation.
Turnkey implementation of SAP Validation Remediation projects for the purpose of audit readiness.
Validation of SAP Fiori Apps
SAP software validation methodology: framework with work instructions for SAP validation are created, implemented and trained.

We either validate based on your CSV framework, work with you to develop your own methodology or have our DHC best practice methodology in place. Our Validation Services include taking over all validation activities – from project management to document production – and include:

Conception of validation strategy, plan and report.
Creation / review of life cycle documents.
Requirement management and process mapping
Project management
Training management
Test management
Data migration and data verification strategies.

Change management
Periodic review
Supplier management
Supplier and service provider audits

Managed Validation Services

With our “Managed Services for Validation”, the effort and costs of IT compliance can be reduced and made transparent. Depending on the initial situation, we offer service packages in the area of Managed Validation Services that are specially tailored to your customer needs. These range from targeted support (Validation as a Service = VaaS) to a full service package.

Depending on the desired level of support, we provide the necessary compliance concept, methods and resources for achieving and maintaining IT compliance. In doing so, we draw on over 25 years of experience in this field.
Detailed info on managed services for validation can be found here.

For all those who want to prepare optimally for the validation of SAP S/4HANA, we have developed the IT Compliance Roadmap.

It includes the following services:

Recording of the current situation in IT with regard to qualification and validation as well as the planned systems:
- Status QMS (FIT/GAP in general and with regard to GxP)
- Overview of current and planned systems (identification of criticality)
- Documentation status of critical current systems
Preparation and presentation of an IT compliance strategy with processes, SOPs and tools; coordination of the roadmap for implementation.
Determination and coordination of the internal and external effort for the realisation.
Documentation and presentation of the roadmap for the implementation of IT compliance

Mohammad Anwar Hossain, Project Manager, SAP project ‘UTTORON’, Deputy General Manager, IT, Incepta Pharmaceuticals Ltd., Dhaka

“DHC made the most effective job in our project. Many of their activities not only assured the goal of a prospective validation of SAP ERP ECC 6.0, but also reduced the project risk. Due to the structured approach with SAP processes and business scenarios and defining the business requirements in URS documents, we were pretty sure, that the new ERP system will cover the daily business of Incepta.”

Work with us to develop the right validation strategy for your S/4HANA transformation and benefit from the new DHC validation approach based on SAP Activate.

Over 25 years of SAP validation and implementation experience
Proven industry expertise in Pharma/Life Sciences and Medical Technology
Many successfully completed prospective and retrospective validation projects
Founded knowledge of regulatory requirements (GAMP, FDA, GxP, ISO 13485, …)
Scalable DHC best practice validation methodology / validation content
High audit security
Tool-supported S/4HANA validation with SAP Solution Manager or VxP
Long-term and trustful cooperation with our customers
Ensuring the transfer of knowledge to you as our customer