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.