GxP Compliance for SAP HLS-A Primer

Published: March 18, 2021

Healthcare and Pharmaceuticals are one of the most important and highly regulated sectors that operate on critical products and services. As per recent statistics, the US spends 18% of its Gross Domestic Product (GDP) on Healthcare with an estimated cost of $1.8 Trillion. On the other hand, consumer spending for healthcare reached 8.1% of total expenditure spent in 2020. This shows the enormous volume of capital, expenditure, and market penetration of the Healthcare and Pharma sector.

Life Sciences and Pharmaceutical companies are subject to stringent regulatory norms by the FDA to ensure that they reach the optimal quality criteria defined for them. It is imperative that companies in the HLS segment comply with regulatory norms that would ensure that they meet the required standards, which also includes the compliance of their software environment.

GxP validation is a set of guidelines and regulations for Life Science and Pharmaceutical companies. These seek to ensure that 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 that are used, is necessary for Health and Life Sciences organizations. In this blog, we look at the basics of GxP compliance within the SAP S/4 HANA Environment, and the different factors for regulating, measuring, and analyzing them for your organization, through a process called as Computer System Validation.

The Importance of GxP validation in HLS Sector

GxP compliance is necessary to regulate the operations in the HLS sector, so that both products and solutions met certain established criteria and standards of quality. The HLS sector is among the most secure industry verticals, and its solutions are mission critical. This brings additional focus on clearing regulatory checks and getting GxP certified in various operational stages in the organization to avoid non-compliance penalties.

Computer System Validation for GxP Compliance in SAP

SAP is one of the most widely used ERP system in the HLS segment. This makes it essential that it is validated for compliance with GxP norms, through a regulatory process called as Computer System Validation (CSV). This covers the entire lifecycle of regulatory validation-starting from implementation to the operations phase, and from decommissioning to archiving. The validation process for 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.

Validation process for GxP Compliance seeks to ensure that all the procedures, processes, and activity establishes a level of compliance at all stages of testing and production. Most relevant to this activity are the documents that Computer System Validation provides, after meeting all the regulatory criteria across the following stages. The Computer System Validation for SAP S/4HANA includes the below stages, and the below Validation Documents which are critical to passing regulatory approvals.

Stages for Validation Documents

User Requirement Specification: This stage defines the specific requirements of the user and ensures that the system meets the ask. It also includes safety and operation requirements and regulations.

Functional Specifications: This focus here is on the functional aspects of the system. It looks at whether the system delivers as per the User Requirement Specification and check the logic and calculations.

Design Specifications: In design qualification, the system environment and requirements are validated. It documents compliance with additional system requirements to ensure these have been prepared, reviewed, and approved.

Installation Qualification: This phase validates the hardware and software installations in the system and ensures that they are compliant with the requirements and are installed as per specifications.

Operational Qualification: This stage ensures that the designed systems work as 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 incudes compliance with requirement specifications.

GxP Impact Assessment: The GxP impact assessment is carried out on all computer systems to ensure that there is no negative impact on quality, patient safety, and data integrity while using them. This is an important checkpoint for GxP compliance in SAP S/4HANA.

Organizations in the HLS sector are increasingly looking to move towards the cloud for the multi-fold advantages that it offers when compared to an on-prem solution. With SAP S/4HANA, they can leverage the many tools and features it offers to meet regulatory GxP compliance and ensure a smooth functioning of their business operations. The idea is to bring in continuous compliance in business processes and infrastructure along with lowering operational costs and increasing agility.

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