GxP compliance and the associated validation efforts are critical considerations in any technology implementation for a life sciences company – but the decisions that affect validation start well before implementation.  

Choices around process standardization or controls can reduce the validation effort required later or add unnecessary complexity. Decisions about data or how the system integrates with other technology can have the same effect. That makes validation an important consideration during ERP selection, even though formal validation hasn’t started yet.  

At this stage, the goal is to understand the requirements that will eventually shape the validated system and consider them as part of the selection process. Doing that effectively requires an understanding of both life sciences requirements and the technology – such as SAP – itself. Industry experience helps translate GxP obligations into practical requirements, while SAP expertise helps determine how the technology can support those requirements.  

Bringing these perspectives together can help identify design decisions that could create unnecessary validation effort while there’s still an opportunity to revisit them. 

The Costly Misconception of a Typical System Selection 

Organizations often follow a similar process for technology selection: they select the system and begin implementation, then determine validation requirements as the project progresses. The challenge with this approach is that requirements may surface after important design decisions have already been made, creating rework during implementation. 

Validation considerations should instead inform the project before implementation is underway. This doesn’t mean completing validation during system selection but rather defining what the organization will need from the system to support its intended regulated use before committing to the technology and its design. 

Why does this matter? 

GxP requirements depend on how a business operates and how the system will support regulated processes. Those requirements also shape the validation effort required. Data flows and risks associated with the system’s intended use also influence those requirements. Understanding these factors early gives teams a more relevant set of criteria for evaluating an ERP system. 

So, what does that look like? For an SAP selection, this means asking questions such as: 

• Which critical business processes will SAP support, and which of those processes are regulated? 
• Where will SAP support electronic records or electronic signatures? 
• What are the system boundaries? Where will SAP be the system of record, and where will another system or external partner remain the system of record? 
• What level of assurance is appropriate based on the risk to product quality or patient safety? 
• Which controls are provided by the technology, and which does the company have to define? What documentation is needed to support those controls? 

These questions help turn regulatory expectations into practical requirements for system selection. Answering them also gives teams a better basis for evaluating how SAP will actually be used, rather than assessing functionality alone. 

Regulatory guidance reinforces the importance of this risk-based approach. Where organizations rely on electronic records or electronic signatures to meet FDA requirements, they need to determine which requirements apply and define controls based on intended use and documented risk. FDA guidance addresses the scope of electronic records and signatures, while its Computer Software Assurance guidance describes a risk-based approach for certain production and quality system software. EU GMP Annex 11 similarly calls for lifecycle risk management, with validation decisions grounded in documented risk assessment. 

For companies selecting SAP, the practical implication is to understand where regulated requirements apply before deciding how the technology should support those processes. 

Turning Requirements into Viable Technology Choices  

Defining GxP requirements early is only useful if teams can translate them into practical technology decisions. In an SAP environment, there may be several ways to address the same business need, with different implications for validation effort. 

Consider the choice between standard SAP functionality and configuring the system for a specific process. An extension may offer additional flexibility, but it can also create more lifecycle ownership. Customization isn’t necessarily the wrong choice. A GxP and validation-aware decision considers whether the additional value justifies the compliance effort required to maintain it. 

SAP expertise is important in making that distinction. A requirement may be clear from a regulatory perspective, but teams still need to understand how different design choices affect auditability and data integrity. A solution can satisfy the underlying requirement while still creating avoidable validation work. 

The same consideration extends beyond SAP itself. Life sciences companies operate across a broader system and data landscape, so teams need to define SAP’s role within it. An integration can affect how regulated data moves between systems and who is responsible for that data throughout the process. Those decisions can influence how the organization demonstrates data integrity and traceability. 

GxP and validation considerations should inform SAP decisions, while SAP design choices can affect the validation effort required later – treating them as separate workstreams can create gaps that are expensive down the line. 

Planning for the Validated State After Go-Live  

The implications of these decisions continue after implementation. Reaching a validated state is one milestone but maintaining that state as the SAP environment changes is an ongoing responsibility.  

SAP environments evolve through releases and enhancements. Business processes and connected systems change as well. When they do, the organization needs to determine how those changes affect the system’s validated state and what assessment or testing is appropriate. Documentation and governance should reflect those decisions. 

Decisions made during selection and design can make that responsibility more manageable. A supportable design can reduce avoidable remediation while giving the organization a clearer understanding of its validation responsibilities as the environment changes. 

This is another reason industry knowledge needs to be paired with SAP expertise. Teams need to understand the regulated requirements as well as the longer-term implications of the technology decisions used to address them. Validation planning should begin when the organization defines how SAP will support its regulated operations, rather than waiting until the configured system is ready for testing. 

Clarkston Value  

Clarkston brings life sciences GxP and validation experience into the SAP decision-making process. Combined with SAP expertise, that industry context helps organizations connect regulated operating needs directly to the technology decisions that support them. 

One tangible outcome is a selection framework that connects business operations and regulatory risk to SAP requirements. It can then provide a basis for evaluating related design decisions and give teams a practical way to evaluate potential solutions according to how the system will actually be used. 

It also helps teams make decisions in the right sequence. They can establish what SAP needs to support before committing to choices that may be difficult or costly to revisit, while distinguishing launch requirements from capabilities that can be introduced later. 

The goal is to make SAP decisions with validation in mind from the beginning, leaving the organization better prepared to maintain its validated environment as the business and technology evolve.