The Indispensable Role of the Business Analyst in Pharmaceutical Validation

 

Assessing business risk is not unique to the Pharma industry.  However, because it's so highly regulated and validated - the cost vs. benefit decisions has unique considerations.  In an unregulated industry, we have the option to kick features over into the next Epic.  But if we defer a feature in the Pharma industry - then it would need to wait until we close out the validation package on the current release and open up a new change control for the next release.  So, we need to continuously ask - how does the timing of this impact business goals?  Will not having the feature for a certain period of time between releases impact a clinical assay or a regulatory submission?   Closing out a validation package, creating a change request, and then validating a new feature will introduce a time and expense cycle that creates a set of tradeoffs that need to be carefully scrutinized.  And because of this, there will be a desire to incorporate even more features into the current release.  So, the process of taking business considerations vs. regulatory requirements becomes an important consideration that can have significant implications.

Below I will break this it down in relation to my personal experience of both general business analysis and the specifics of regulated pharmaceutical environments:

1. Risk Assessment Is Universal, But Constraints Differ

• Universal aspect: In every industry, we must weigh the cost vs. benefit, timelines vs. features, and scope vs. resources. That’s a fundamental BA activity.
• Pharma-specific nuance: In regulated environments, you don’t just evaluate business risk - you must simultaneously evaluate compliance and validation risk. That dual lens makes every decision carry even more downstream weight.

2. Deferred Features Have Different Implications

• Unregulated context: If a feature is pushed to the “next Epic,” there’s little overhead beyond backlog reprioritization and stakeholder alignment. Agile thrives in this type of environment.
• Pharma context: Deferring a feature means more than reprioritization. It means closing the current validation package, opening a new change control, re-planning test scripts, and re-executing validation activities. That brings both direct cost (additional validation) and an indirect cost (potential impacts to R&D timelines for a specific assay, for example).

3. Timing Directly Affects Business Goals

• Clinical assays: Delays could mean impacts to study timelines.  For example, if the system cannot produce a complete chain-of-custody record directly for a clinical sample, then scientists may need to implement a procedural workaround (by reconciling assay results containing sample IDs across multiple systems in order to ensure readiness for a potential FDA inspection).
• Regulatory submissions: A deferred feature might mean data end up not being captured in a particular format - which ends up creating workarounds in order to align with submission standards.  For example, users must extract raw data from multiple spreadsheets and reformat into a compliant schema vs. the system auto-generating summary tables.

4. The Compounding Effect

Because validation and regulatory frameworks impose high fixed costs per release cycle, there’s a natural incentive to add “just one more feature” before closing out a package. This can:

• Extend delivery timelines
• Increase complexity in testing and validation
• Potentially introduce greater risk if scope isn’t carefully managed

This “snowball effect” has a compounding impact within Pharma, where compliance is inseparable from delivery. Each change control cycle adds overhead - which encourages organizations to “bundle” features. But this bundling also slows agility and can create larger risk packages.

5. Conclusion

In Pharma, assessing business risk cannot be separated from regulatory and validation considerations. Therefore, the BA role becomes not only about eliciting and prioritizing requirements - but also about helping stakeholders understand the true cost of deferral and timing decisions in the context of compliance. This is where the Pharmaceutical Business Analyst becomes indispensable - by bridging business priorities with regulatory realities. And ensuring that complex validation constraints are factored into every decision that influences timelines and costs - which ultimately impacts patient outcomes.

 

AI and the Business Analyst: A Partnership, Not a Replacement

 

Over the past year, I’ve been experimenting with how AI can support my work as a Business Analyst. The results have been impressive when it comes to increasing my own personal efficiency. But as valuable as AI has been - my recent experience with being onsite every day has reminded me that there is still no substitute for the human element of being a Business Analyst.

Where AI Shines

AI has proven itself to be a powerful assistant in areas that demand speed, structure, and consistency. For example:

• Stakeholder Preparation: Generating thoughtful and targeted questions ahead of elicitation sessions.
• Documentation Support: Turning lengthy meeting transcripts into clear minutes or translating raw notes into draft requirements.
• Test Planning: Creating draft test plans and traceability matrices that can provide a great starting point.
• Scalability: Quickly processing large volumes of information across meeting minutes, requirements, and test cases.

In all of these areas, AI functions have been very valuable with saving me hours of manual effort, maintaining consistency across deliverables, and even generating new ideas or perspectives that I might not have considered.

The Key Principles of Effective AI prompting

Leveraging AI means providing it with clear and specific prompts so that it fully understands your request.  As a Business Analyst, I need to know enough about the subject matter so that I can prompt it with the appropriate context and details.  The more ambiguous the instructions, then the less likely the response I receive will provide me with the answer I’m looking for. It’s also critical for me to provide the relevant inputs when generating the prompt.  Incorporating inputs which are irrelevant - or overloading it with too many unclear inputs - can cause it to provide a watered-down or even improper response that's not valuable.  Additionally, it's important to be patient and willing to iterate.  When receiving a response that isn’t what you’re looking for - then take the time to build upon that response and refine the questions until you get the right answer.  Ultimately, you’re still working with a computer - and so it’s only through actual usage that you will grasp how AI systems rely on your input and cannot infer unstated details. Finally, the most important aspect of this is that you must check and verify all of the outputs received.  Do not take what it gives you at face-value.  This is where your expertise as the Business Analyst becomes unique - because only you understand your audience, the context you're operating in, and what you’re ultimately trying to deliver.

Where the Human BA Is Irreplaceable

Moreover, the job of a BA isn’t just about producing documents - it’s also about people. That’s where role of the Business Analyst cannot be replaced by AI:

• Contextual Understanding: Knowing what information is truly relevant, feasible, and politically acceptable.
• Conflict Resolution: Acting as a diplomat to address competing priorities and underlying resistance to change.
• Influence and Trust: Building credibility with stakeholders, reading the room, and tactfully guiding conversations.
• Observation and Nuance: Picking up on non-verbal cues, situational conditions, and the “unwritten rules” of how work actually gets done.

These tasks cannot be delegated to AI - they require empathy, judgment, and presence.

The Impact of Being Onsite

My client has recently asked me to be onsite daily to assist with a critical initiative. While AI remains invaluable for preparing artifacts and accelerating documentation - being physically present has underscored the irreplaceable aspects of the human BA role:

• Translating hallway conversations and observations of stakeholders performing their daily tasks into meaningful requirement updates and test scenario refinement.
• Making real-time decisions when discussions require considering context to develop a shared understanding.
• Building trust by showing stakeholders that I am committed, attentive, and invested in their success.

The Bottom Line

There's no question that AI has helped me with being faster and more thorough at my job. But my effectiveness ultimately depends on human insight, empathy, and diplomacy.  Therefore, AI and Business Analysts aren’t in competition - they’re partners. AI automates and accelerates the mechanics of analysis, while the BA brings the human judgment and influence that ultimately enables successful business outcomes.