How SAP S/4HANA Validation Reduces Compliance Risks in Regulated Industries

Enterprise Resource Planning systems play a vital role in the life sciences industry. They have transformed the way these organizations operate and streamlined their processes. 

Leading the way in Enterprise Resource Planning (ERP) systems that address an organization's daily operations and core competencies is SAP S/4HANA. Developed by SAP SE, SAP S/4HANA was published on February 3, 2015, and has grown to be one of the most popular systems in the life science industry. 

Implementation of SAP S/4 HANA 

There are different approaches to migrating to S/4HANA, which depend on where the customer is starting from. Options include new implementations, system conversions, and selective data migrations. 

• New implementation – This refers to the process in which customers transition from a legacy system that is not SAP or from an existing SAP ERP system to a brand-new system that necessitates an initial data load. In this case, the SAP S/4HANA system is set up, and both master and transactional data are moved from the legacy system, which requires the use of standard data migration tools and content. 

• System conversion – This refers to the process in which customers aim to transition their existing SAP ERP system to SAP S/4HANA. This situation is typically executed using the Software Update Manager (SUM) along with the Database Migration Option (DMO) if the client has not already migrated to SAP HANA as their database. 

• Selective Data Transition – This refers to the process in which customers aim to streamline their environment or extract specific entities (like a company code) or processes into a unified SAP S/4HANA system. 

Compliance Risks of SAP S/4 HANA 

Life sciences is a highly regulated industry where the reliability and accuracy of computerized systems are crucial for maintaining compliance with strict regulatory standards. Adherence to regulations and standards, such as FDA CFRs, EU GMP, and the International Organization for Standardization (ISO) for medical devices, is necessary to safeguard product quality, ensure patient safety, and preserve data integrity. 

SAP Business Suite 4 SAP HANA is an enterprise resource planning (ERP) solution designed to leverage SAP’s in-memory computing platform, SAP HANA. S/4HANA is the preferred choice for leading companies in the pharmaceutical, medical device, and biotechnology industries. 

These complex environments require extensive capabilities, and S/4HANA provides a powerful solution with industry-specific functionalities tailored for Life Sciences. It can be deployed on-premises, in the cloud (either public or private), or in a hybrid model. The SAP S/4HANA On-Premises deployment scenario means that a company manages its own server, database, applications, and data center. 

The company is responsible for maintenance when SAP releases upgrades that must be implemented and tested. An on-premises solution is ideal for organizations that require a high level of flexibility for system customization and have a dedicated IT staff to manage extensive maintenance tasks. In contrast, SAP S/4HANA Cloud is a fully managed option where SAP takes care of the maintenance of the hardware, software, and databases. This solution offers an agile platform for rapidly growing companies that need flexibility. Additionally, hybrid options are available, which allow organizations to operate S/4HANA in an Infrastructure-as-a-Service (IaaS) mode. 

The Arbour Advantage 

Arbour Group specializes in software validation for SAP S/4HANA, adhering to the standards set by the ISPE GAMP Guidelines. Our team brings extensive industry knowledge and expertise gained from years of experience working with pharmaceutical, medical device, and biotechnology companies. 

Our SAP compliance product enables you to fulfill your obligations to both domestic and international regulatory authorities efficiently and cost-effectively. 

The Arbour Service Offerings 

ERP systems in the Life Sciences sector, whether hosted on-premises or in the cloud, must undergo validation to meet regulatory agency requirements. SAP S/4HANA adheres to data privacy laws and industry-specific data protection regulations. Its compliant virus scan interface is designed to enhance system security. However, it is important to note that SAP does not take responsibility for ensuring regulatory compliance of the software. Arbour Group provides global regulatory expertise and high-quality consulting services tailored for Life Sciences companies. 

Compliance: 

To minimize manual and labor-intensive validation efforts, Arbour Group provides a comprehensive validation package that includes best practices for industry compliance as outlined below: 

• Business Requirements model 

• Validation Plan template 

• Traceability Matrix template 

• Installation Qualification test scripts 

• Operation Qualification test scripts 

• Performance Qualification template 

• Validation Summary Report template 

The Arbour Assurance 

Arbour Group’s SAP S/4 HANA validation product provides maximum investment protection with the following primary benefits: 

• Shorter Timeframes – Our time-tested, field proven pre-packaged validation product certifies compliance in an optimally expedient and secure manner. This means you are able to accelerate the time-to-value of your commercial business software investment. 

• Regulatory Agency Approval – Validated solutions are less likely to face regulatory scrutiny, such as citations and audits. These time-consuming and disruptive events can pose significant risks to businesses, particularly when it comes to gaining agency approval for new product introductions and achieving brand acceptance in the marketplace. 

Whether you are implementing SAP for the first time, transitioning from an old system, or applying a software update, Arbour Group’s pre-packaged validation solution will assist you in managing your business risks efficiently and effectively. Arbour Group is looking forward to partnering with you!  

Learn about our Validation Packages.