IT system validation in Life Science – SAP as support
SAP provides access to integrated solutions for companies across various industries, including Life Science. The system can offer significant support in the IT system validation process, with functions tailored to applicable regulations. For the process to run smoothly, it is essential to combine technical expertise with up-to-date regulatory knowledge and effective risk management.
How to avoid the numerous pitfalls of SAP validation? Life Science is undoubtedly a demanding industry, but the support of an experienced implementation partner is the key to success.
Effective SAP validation – Life Science
To ensure that SAP S/4HANA supports Life Science organizations in a compliant, safe, and secure manner – not only for patients, but also for processes and data – it is important to include several core elements in the IT system validation process. These involve adopting a System Development Life Cycle approach, conducting early-stage risk assessments closely linked to the criticality of system functions, clearly defining user requirements, mapping processes with transparent test documentation, and ensuring data integrity in line with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available).
It is important to remember that SAP validation in the Life Science industry should be carefully planned. Improvised actions in this area can lead to costly errors. Validation should be taken into account during the system implementation planning phase to avoid the need for adjustments to already established processes.
SAP validation in Life Science and regulations
Life Science companies are required to operate in compliance with specific regulations, such as FDA 21 CFR on electronic records and signatures, GxP guidelines on quality, safety, and process integrity, and EMA regulations on the supervision of medicines for human and animal use. This means that all functionalities of the implemented system should be properly documented and verified, and every change must be recorded in the validation documentation repository.
Considering that the Life Science industry is among the most heavily regulated in the world, the consequences of non-compliance can be severe. These may include financial penalties, suspension of processes, and loss of credibility.
Addressing the specific nature of Life Science – SAP in the implementation phase
In the context of SAP validation in the Life Science industry, risk management is of particular importance. Every system component can potentially impact product quality or patient safety. Failure to verify the system may lead to errors in clinical trial results and cause delays in bringing new therapies to market.
SAP validation in Life Science should be performed multiple times. Not only during implementation, but also following system changes and updates. The continuous nature of this process helps reduce the risk of non-compliance. The benefits of properly conducted validation include ensured regulatory compliance, greater operational transparency, and time savings by eliminating the need for later error correction. SAP provides Life Science organizations with the tools they need to meet regulatory requirements through advanced data and documentation management capabilities.
Collaboration with a specialized validation team offers reliable support in digital transformation. Hicron Validated S/4 Life Science is a service offered by Hicron that combines SAP implementation with comprehensive system validation.
