1.Introduction
In regulated industries, when a new software system comes online — be it a laboratory information management system (LIMS), an enterprise resource planning (ERP) platform, or a cloud-based application — one question inevitably arises: “Who will validate this system?”
Almost immediately, organizations think of the CSV or CSA consultant. And almost immediately, a misconception appears: that the consultant must be a system expert — a technical wizard who knows every screen, configuration, and line of code.
This misunderstanding is common, and it stems largely from how regulated users traditionally perceive validation: IQ, OQ, PQ. Let’s unpack this and clarify what a CSV/CSA consultant really does, why deep technical expertise is often unnecessary, and how organizations can better align expectations — especially in today’s technology-driven environment.
As a consultant, he/she doesn’t need to know every detail of every system. He/She needs to understand the intended use, data flows, and risks well enough to determine what must be validated, how assurance is achieved, and how that aligns with regulatory expectations.
2.The Legacy IQ/OQ/PQ Mindset
For decades, validation was synonymous with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). These three pillars are concrete, auditable steps:
- IQ ensures the system is installed correctly.
- OQ verifies the system operates as intended.
- PQ confirms it performs consistently in real-world scenarios.
Because these steps involve detailed testing — clicking through screens, checking configurations, documenting results — many regulated users assume that a consultant must know the system in exhaustive detail.
The thought process is understandable: if the consultant doesn’t know the system like a power user, how can they validate it?
Unfortunately, this narrow view can create two problems:
- Overloading the consultant with technical expectations that are outside the regulatory role.
- Misaligning validation with its true purpose, which is to demonstrate the system is fit for its intended use and compliant with regulatory requirements.
3.What CSV/CSA Consultants Actually Do
A competent CSV or CSA consultant is primarily a regulatory and risk-based strategist, not a system operator. Their expertise lies in:
- Understanding the system’s intended use: What critical business or GxP processes does it support?
- Assessing risk: Which functionalities are essential for compliance, data integrity, or patient safety?
- Designing validation strategies: How can we provide assurance efficiently and effectively?
- Guiding testing and documentation: Which tests are necessary to demonstrate control effectiveness and compliance?
- Interfacing with subject-matter experts (SMEs): SMEs provide deep technical and operational knowledge, while the consultant ensures regulatory rigor.
In short, the consultant does not need to configure the system, troubleshoot it, or know every menu option. Their role is to make sure that the right questions are asked, risks are mitigated, and compliance is documented.
4.Translating Modern IT into Regulatory Terms
In today’s technology-driven world, CSV/CSA consultants also serve as regulatory translators. Modern IT terms — cloud platforms, data lakes, AI algorithms, microservices, IT services — must be mapped into regulatory concepts such as:
- 21 CFR Part 11.1(e) defines a computer system as any combination of hardware and software that performs a regulated function.
- EU Annex 11 — provides principles for computerized systems without tying them to specific technologies.
A CSV/CSA consultant does not need to become an AI expert or a cloud engineer, but they must know enough to decide which components are critical, what controls are required, and how assurance can be demonstrated.
5.The Role of CSA in Modern Validation
Computer Software Assurance (CSA) has brought a significant shift in mindset. Unlike traditional CSV, CSA encourages a risk-based, critical-thinking approach:
- Focus only on critical functions that impact compliance or patient safety, product quality and data integrity.
- Leverage vendor testing and evidence rather than reproducing exhaustive IQ/OQ/PQ tests. It must comply with company procedures and requirements on testing plus following the good documentation practices.
- Reduce unnecessary documentation and testing, freeing time for regulatory analysis and risk management.
CSA explicitly demonstrates that deep system knowledge is not a prerequisite. What matters is understanding the system’s impact, identifying critical points, and ensuring regulatory objectives are met.
6.Why Misunderstandings Persist
Despite the shift, the perception that consultants must be technical experts persists. Here’s why:
- Historical practice: Legacy validation focused heavily on exhaustive IQ/OQ/PQ testing.
- Audit anxiety: Users fear that if auditors ask questions, only someone with technical depth can answer.
- Complex systems: Modern applications are highly configurable, so it’s tempting to equate familiarity with competence.
- Poor role communication: The consultant’s responsibilities are often described vaguely as “validating the system,” which users interpret as “operating it.”
7.Aligning Expectations
To prevent misunderstandings, organizations should clearly communicate the CSV/CSA consultant’s role:
- Regulatory strategist – ensuring compliance and data integrity, and security at a specific way, i.e., at the level of regulatory judgment and risk assessment — not at the level of technical implementation.
- Risk assessor – identifying what truly matters for compliance.
- Regulatory translator – converts modern IT terminology (AI, cloud, microservices, data lakes) into validation scope and critical controls and is responsible for correctly classifying systems and components by determining whether they constitute a GxP computer system under 21 CFR Part 11 and Annex 11 and defining the appropriate validation and assurance approach.
- Advisor and guide – supporting SMEs, system owners, and operational teams.
- Not a system administrator or developer – technical system operation remains the responsibility of SMEs.
A simple explanation for teams could be:
“Validation is not about having in depth technical knowledge of IT systems presented in architectural diagram. It’s about ensuring the system reliably performs critical tasks meeting business intended purpose aligned with regulatory expectations. While IQ, OQ, and PQ are often presented as “validation” by some consultants, they are in fact just tools to provide evidence. The true role of a CSV/CSA consultant is to design, guide, and assure the validation process based on risk and regulatory principles, while SMEs provide the detailed system knowledge.
8.The Bottom Line
CSV/CSA consultants are regulatory and risk-focused professionals, not system superusers. Their value lies in:
- Translating regulatory requirements into actionable validation strategies
- Identifying critical functions and controls
- Converting modern IT concepts into compliance-relevant scope
- Ensuring the right evidence is generated for audits
- Protecting patient safety and data integrity
Deep technical knowledge of the system, while sometimes helpful, is not the measure of a consultant’s competence. Organizations that cling to the old IQ/OQ/PQ mindset risk overloading consultants, misaligning expectations, and missing the point of validation.
By clarifying roles, focusing on risk and compliance, and leveraging SME expertise, teams can ensure validation is efficient, effective, and aligned with modern CSA principles, even in a world of AI, cloud services, and complex IT architectures.
If you are interested in sharing your perspective on this topic, I would kindly appreciate receiving your comments at: milan.kucera@d2i.cz
