Implementing SAP S/4HANA in Life Science companies is not just a technological challenge, but also a major regulatory one. GxP regulations – including those established by the FDA and EMA, and covering requirements related to electronic records – require that all functions critical from a GxP perspective be properly documented and confirmed to comply with good manufacturing practices. Validation of newly implemented ERP systems in Life Science has therefore become a critical project component. Unfortunately, organizations sometimes make mistakes that can be costly and have a negative impact on business operations. To ensure a secure and successful business transformation, it is important to understand which areas require particular attention. This is the only way to avoid issues during the implementation of SAP S/4HANA in the Life Science sector.
1. Including validation too late in the project schedule
One of the most common SAP project validation issues is treating validation as the “final step” or a formality that can be handled in the last stages of the undertaking. Meanwhile, effective ERP validation in Life Sciences must be considered from the very beginning of the implementation planning stage. Failing to involve the validation team early on can lead to delays, duplicated work, or even the need to modify already finalized processes. Validation best practices in SAP involve joint planning of IT and compliance activities right from the start. This significantly increases work efficiency and reduces the risk of non-compliance. The validation of already implemented systems (so-called legacy system validation) is complex and sometimes even impossible.
2. Insufficient documentation and lack of audit trail
Documentation is the backbone of any validated system. Its absence or non-compliance with GxP requirements can completely disqualify the project during an inspection. Companies often make the mistake of copying template documents or generating documentation after system implementation, rather than developing it alongside the project. Meanwhile, every test, project decision, change, and deviation should be reflected in the validation documentation repository. Only then can the organization demonstrate compliance when requested by GIF inspectors.
3. Lack of an appropriate validation partner
In a regulated environment, IT competencies alone are not enough. It is also necessary to understand the complex relationships between technology and good manufacturing practice compliance requirements in a broader context. There are cases in which a pharmaceutical company chooses to carry out an implementation project with partners experienced in implementing SAP systems. However, in such situations, the implementation team may fail to follow proper documentation practices and underestimate the significance of the connection between system implementation and medicinal product compliance. It is also not uncommon for implementation partners to lack experience with projects that involve system validation. As a result, the implemented software is not properly verified during the design phase or subjected to adequate testing during prototype development. What does this lead to? Compliance errors in SAP S/4HANA, the need to repeat testing, and even the risk of suspending the system’s release to the operational phase. The solution in this case is to partner with a company like Hicron, which offers the Hicron Validated S/4 Life Science solution – combining SAP S/4HANA implementation with comprehensive system validation in accordance with FDA, EMA, GxP, and other regulatory requirements, as needed. This not only saves time and reduces risk, but also ensures full inspection readiness from the moment the system goes live.
4. Undefined risk and acceptance criteria
Another pitfall in SAP S/4HANA validation that can catch unprepared companies off guard is the lack of clear success criteria for individual testing stages and the absence of a systematic approach to risk assessment.
In the case of Life Science, in addition to standard project risk management, it is essential to account for the so-called quality risk as well. It identifies potential risks related to project implementation that may affect the quality of the medicinal product and patient safety. It is also related to data integrity and regulatory compliance. The analysis and mitigation of this risk form the foundation for decision-making and planning validation activities at every stage of the project.
Therefore, it is important to note that in the Life Science sector, risk management is not optional – it is mandatory. Companies that fail to implement a formal validation approach based on regulatory requirements and GAMP 5 best practices expose themselves to nonconformities that are difficult to resolve after implementation.
5. Maintaining the system in a validated state
The ERP system in the Life Science industry grows alongside the organization. For example, the organizational structure may change, master data may be updated, new functionalities may be introduced, and others may become obsolete – all of which can have a critical impact on system security. Therefore, confirming system compliance cannot be treated as a one-time activity. Such changes are managed in accordance with the change control process. A common mistake organizations make is treating validation as a “finished chapter”. In practice, every system change, update, or deployment in a new location requires revalidation to ensure ongoing compliance. Hicron supports companies in maintaining compliance by integrating ITIL-based support processes with validation activities in accordance with the change control process.
How to avoid compliance errors in SAP S/4HANA and implement the system in line with regulatory requirements?
Digital transformation in Life Science cannot be left to improvisation. SAP S/4HANA validation is a strategic component that determines project effectiveness, regulatory compliance, and implementation predictability. The key to success is partnering with an expert who understands both sides of the equation: the modern SAP cloud technology and the regulatory requirements of the Life Science sector.
