When to Involve the Validation Team in a Life Sciences SAP S/4HANA® Project
When to Involve the Validation Team in a Life Sciences SAP S/4HANA® Project
If you're planning or involved in an SAP S/4HANA project at your company, it's worth investing 7 minutes to read this blog.
Many SAP S/4HANA® validation Life Sciences projects fail not because of technology, but because validation is introduced too late.
The first steps, understanding how, why, and when to begin your SAP® validation, are crucial to the success of the project. In regulated industries such as pharmaceuticals, biotechnology, and medical devices, implementing a system like SAP S/4HANA requires collaboration among IT, operations, quality, and validation teams to ensure compliance.
This raises a critical question for regulated companies: when to start SAP validation to avoid rework, delays, and compliance risks.
A computerized system goes through several stages, from its inception to its decommissioning. The GAMP5 SAP validation approach (GAMP5® Second Edition) describes this journey in four main phases: Concept, Project, Operation, and Retirement.
The Concept Phase: Laying the Foundation
This is where your strategic thinking begins. Companies should evaluate opportunities to automate processes based on business needs and benefits. Typically, this involves developing initial requirements and exploring possible solutions.
Many organizations start with a discovery phase, a detailed look at current processes, technologies, and risks. This step helps teams gather the right insights to create a well-defined and accurate User Requirements Specification (URS) that matches business needs, ensuring the system delivers as expected.
In SAP regulated industries, a well-defined URS provides the clarity and traceability needed to avoid late rework and compliance gaps.
Why is this approach impactful?
Requirement accuracy: Basing the URS on an understanding of existing processes and needs.
Minimized rework: Detailed insights prevent the creation of vague or incomplete items, saving time and resources later.
The Power of Early Validation Integration
The best approach is to involve validation before the project starts, before selecting and contracting the implementation partner.
If validation is performed by an external partner, this provider should be engaged before the implementer. The reason is practical: one of the first and most important validation deliverables is the User Requirements Specification (URS).
A well-defined URS can be attached to the implementation contract, making the scope clear from day one. This increases transparency and helps the implementation partner estimate the true project effort, including the need for custom transactions, system interfaces, and other regulated requirements, reducing the risk of unexpected costs due to inaccurate initial estimates.
When validation is brought in later, these elements are often discovered after design decisions have already been made, which can lead to scope changes, renegotiations, delays, and additional costs.
Why early SAP validation matters in regulated industries:
To define the testing scope, the functional requirements and risk assessment should already be completed and approved. Many companies realize late that the validation team should have been included from the start.
Important: Even if the system has already been purchased and a URS wasn’t planned from the start, it’s still well worth creating one. While it may involve some additional effort or cost, developing a URS later is recommended to support validation and ensure traceability, especially since the system will be customized to fit your business processes.
This is not only a project timing decision, it is part of a broader SAP ERP validation strategy that connects requirements, risk assessment, and testing to the real business process.
Beyond Integration Testing: Adding Value with a Dedicated OQ¹ Phase in ERP Validation
Besides offering validation services, the company has developed the digital validation platform GO!FIVE®, which provides clients not only with ERP validation projects but also many other types of validation activities. These include:
- Various computerized systems
- Qualification of IT and OT infrastructure
- Electronic spreadsheets
- Systems used in R&D processes and clinical studies
- Management systems
- Quality Control (QC) systems
- Utilities
- Production software and equipment, among others
SAP S/4HANA® implementation, rollout, or conversion projects are well-suited for digital validation because they are multidisciplinary by nature and challenging to manage using paper-based processes, especially when dozens of key users are involved.
Another way digital validation adds value is by helping manage large volumes of tests. For example, in some SAP® validation projects, we've issued validation documents where the OQ1 (Operation Qualification) test scripts alone generated thousands of PDF pages automatically, without needing manual formatting. That’s a lot of testing!
- Following the GAMP5® guideline, the OQ phase, particularly in the case of software, may also be referred to as Functional Testing.
Speaking of testing… we've had the opportunity to validate several SAP S/4HANA® system validation projects, as well as many ECC systems and ERPs from other vendors. Based on our experience, it's important to plan for a third testing phase.
Typically, implementation partners plan for unit testing and integration testing as the two main testing phases. Due to tight timelines, some clients ask us to conduct the Qualification Testing (OQ) alongside phase 2, together with the implementation partner.
At first glance, this approach might seem agile and efficient, but a key counterpoint should be considered:
When the validation team is executing tests, their scope has been previously defined during the Functional Risk Assessment. Therefore, these tests require prior approval and a higher level of formality, such as evidence collection and detailed documentation of the test execution.
If a test fails, an incident must be opened to document the reason for the failure and the next steps, which typically include re-executing the test, aborting it, or modifying it. This incident should also be formally approved before the process can move forward, just as the original test had to be approved before execution.
In short, this level of formality often slows down the progress of integrated testing. It's expected for test failures to occur; that's the purpose of testing: to identify and correct issues before the system goes live.
While adding a third testing phase may seem to make the project longer, in practice, it’s more efficient. That's because there’s no need to apply validation formalities to all integrated tests. These can be reserved for the dedicated validation phase, where the system is expected to be stable and closer to how it will perform in operation. In summary, a third testing phase (focused on validation) should be included in the project timeline.
Likewise, the timeline should account for all steps involved in validation activities, including planning, drafting, reviewing, and approving each deliverable. Special attention should be given to allocating sufficient time for Functional Risk Assessment discussions, which often take several days and are essential for defining mitigation actions and the scope of validation testing. This extended risk assessment phase is often underestimated or neglected during conversion or deployment planning. Implementation partners that understand the importance of aligning validation with implementation activities are valuable for the regulated Life Sciences industry, and these partnerships should be both preserved and recognized.
Item-Level Version Control: A Smarter Way to Maintain the Validated State
After a lot of effort to convert, implement, or deploy the SAP S/4 HANA® system, you don’t want to lose the validation status, right? It can be challenging.
GO!FIVE® digital validation tool uses item-level version control instead of versioning entire documents.
This approach makes it easier to update only the elements that have changed. It simplifies change management by allowing traceability at the item level, including change control numbers, and enables those updates to be embedded directly into the original documents, tracking the date, version, author, and linking each change to its corresponding Change Management (CM).
This capability supports an audit-readiness approach encouraged by the FDA, where validation documentation is kept current, rather than relying on an outdated original version followed by a series of appended changes that contradict or override it.
Accelerate SAP S/4HANA® Validation with Ready-to-Use Digital Templates
Imagine if you could run your SAP S/4HANA® validation project in a digital and agile way, starting from a template that has already been used successfully in multiple projects. That’s exactly what the GO!FIVE® platform offers with over 70 validation templates built on the best regulatory practices and data integrity principles.
SAP validation projects are typically long and expensive but using a digital and agile platform like GO!FIVE® offers an excellent cost-benefit ratio, making your project faster, more efficient, and more economical.
Ready to streamline your SAP validation project? Discover how GO!FIVE® can help you reduce costs, avoid rework, and ensure compliance from day one.
Key takeaways for Life Sciences SAP projects:
SAP validation should start before implementation contracts are signed
The URS is a strategic document, not a formality
A dedicated validation testing phase improves efficiency
Digital validation supports long-term audit readiness
Conclusion
By adopting a logical, strategic approach rooted in GAMP5® principles and critical thinking, organizations can reduce risks and streamline the journey toward a successful SAP deployment. Remember, the way you initiate your project influences the entire lifecycle; set it up for success from the first step.
Reference
SAP® and S/4 HANA® are registered trademarks of SAP in Germany and other countries. All rights reserved. For more details, refer to https://www.sap.com/about/legal/trademark.html
GAMP5® is a guide that has its intellectual rights reserved by ISPE®. Available for purchase at https://ispe.org/.
