Healthcare and Pharmaceuticals are among the most important and highly regulated sectors operating on critical products and services. As per recent statistics, the US spent 17.4% 1 of its Gross Domestic Product (GDP) on Healthcare in 2022. Such a focus shows the enormous importance of the sector, and the keen focus on ensuring the safety of end-users. If you are running a HLS organization, there are essential guidelines to be followed, which will be covered in this blog.
Life Sciences and Pharmaceutical companies are subject to stringent regulatory norms by the FDA to ensure they reach the optimal quality criteria. Companies in the HLS segment must comply with regulatory norms that would ensure that they meet the required standards, including the compliance of their software environment.
What is GxP
GxP validation is a set of guidelines and regulations for Life Science and Pharmaceutical companies. These ensure their products are safe, meet intended use, and adhere to strict quality processes during manufacturing, storage, and distribution. In GxP, "G" stands for Good, and "P" for Practice. The "x" refers to various processes such as M for "Manufacturing," C for "Clinical," L for "Laboratory," S for "Storage," D for "Distribution," R for "Review," etc.
A certification for GxP compliance across all core operations and solutions is necessary for Health and Life Sciences organizations. Let’s look at the basics of the activity within the SAP S/4 HANA Environment and the different factors for regulating, measuring, and analyzing them for your organization through Computer System Validation.
The Importance of GxP Validation in the HLS Sector
GxP compliance is necessary to regulate the operations in the HLS sector so that both products and services meet specific established criteria and standards of quality. The HLS sector is among the most secure industry verticals, and its offerings are mission-critical. There is an imperative focus on clearing regulatory checks and getting GxP certified in various operational stages to avoid non-compliance penalties.
Computer System Validation for GxP Compliance in SAP
SAP is one of the most widely used ERP systems in the HLS segment. Compliance with GxP norms involves a regulatory process called Computer System Validation (CSV). It covers the entire regulatory validation lifecycle starting from implementation to the operations phase and from decommissioning to archiving. The validation process for the SAP S/4HANA environment in HLS covers the complete HANA landscape in that organization. It aims at regulating all the major functions, including production, distribution, supply chain, and other associated modules.
The validation process for GxP Compliance seeks to ensure that all the procedures, processes, and activities establish a compliance level at all testing and production stages. Most relevant to this activity are the documents that Computer System Validation provides after meeting all the regulatory criteria as below.
The Computer System Validation for SAP S/4HANA includes the below stages and associated validation documents, which are critical to passing regulatory approvals.
Stages for Validation Documents
User Requirement Specification: This stage defines the user's specific requirements and ensures that the system meets them. It also includes safety and operational requirements and regulations.
Functional Specifications: The focus here is on the functional aspects of the system. It looks at whether the system delivers as per the User Requirement Specification and checks the logic and calculations.
Design Specifications: Design Qualification ensures validating the system environment and requirements, with preparation, review, and approval of the documents.
Installation Qualification: This phase validates the hardware and software installations in the system and ensures that they comply with the requirements and installation specifications.
Operational Qualification: This stage ensures the designed systems work per the intended operational specifications. It is similar to functional testing and is related to the design specifications.
Performance Qualification: Performance Qualification ensures that the entire system performs as per the performance requirements in all operating stages. It is similar to user acceptance testing and includes compliance with requirement specifications.
GxP Impact Assessment: The GxP impact assessment is carried out on all computer systems to ensure no negative impact on quality, patient safety, and data integrity while using them. This stage is an essential checkpoint for GxP compliance in SAP S/4HANA.
Organizations in the HLS sector are increasingly looking to move towards the cloud for its multi-fold advantages compared to an on-prem solution. With SAP S/4HANA, you can leverage the many tools and features it offers to meet regulatory GxP compliance and ensure the smooth functioning of business operations. The idea is to bring continuous compliance in business processes and infrastructure, lowering operational costs and increasing agility.
If you are looking for GxP compliance solutions for your healthcare organization, contact us, and we will be glad to help.