Roche Diagnostics — Labeling Visual Tracking System

Timeline

May 1, 2023

Problem

Critical medical labels were trapped in unstructured cloud drives. Due to multi-source collaboration (e.g., 5 identical files created by different designers), compliance officers had to manually cross-reference PDFs across dual monitors to spot changes. Critical FDA justification metadata was frequently lost in emails, creating a massive systemic audit risk.

Solution

Engineered a centralized medical labeling version control platform for Roche’s Labeling teams. By introducing "forced FDA validation" and "visual diffing," the system eliminates the compliance blind spots of multi-source files, achieving 100% audit traceability for labeling assets.

Before

Dropbox with exclusive access to Labeling team

Label guidelines and updates scattered around internal Dropbox folders, and multiple versions live across multiple locations.

After

Dashboard for open cross teams access

Unified Labeling Tracking platform records all updates along with version rationale. It keeps assets under one roof for easy auditing.

Feature Highlight

From Dark Archive to FDA-compliant database

I transformed an un-auditable "dark archive" into a transparent, FDA-compliant database, drastically reducing compliance risk and cross-functional retrieval time.

The Visual Diff & Audit Trail compares versions of Label

In medical device labeling, a 2pt font change is a regulatory event. I designed a side-by-side visual diff tool paired with a chronological audit trail, allowing compliance officers to verify microscopic changes without digging through emails.

"We would routinely find 5 different versions of the same label floating around between different designers. Putting them side-by-side to figure out what changed—and more importantly, why—was a compliance nightmare." — Regulatory Affairs / QA Specialist

New Label Intake with mandatory FDA justification to prevent excessive orphan files

Because unstructured uploads created orphan files, I designed the Forced Commit Modal, requiring users to log 21 CFR Part 11 (FDA) justifications before an upload is permitted. This significantly improves the clarity of audit trails, rationale, and prevents piling of low value label uploads.

Research Findings

Qualitative audits revealed Label related pain-points

“We would routinely find 5 versions of the same label. Putting them side-by-side to figure out what changed — and why — was a compliance nightmare.”

Regulatory Affairs & QA

70%

Orphan Files (No FDA context)

Manual

Dual-monitor verification.

Siloed

Single-team dependency.

Frictionless uploads stripped critical 21 CFR Part 11 metadata from the audit trail.

Critical Liability

"Tribal knowledge" isolated regulatory truth to a single point of failure.

Systemic Vulnerability

Human-reliant PDF cross-referencing created an unacceptable margin for error.

Cognitive Bottleneck

Research → Design

Design Rationale — Features resulted from internal Workflow Audits

The findings from our internal labeling audits served as the exact blueprint for the platform's architecture. Rather than relying on assumptions, documented compliance failures were directly translated into hard-coded UI constraints, transforming operational friction into a structural safeguard.

Workflow Architecture

Friction as a Feature

Benchmarking against tools like GitHub proved that MedTech requires structured friction, not B2C "seamless uploads." This architecture prioritizes data integrity over speed. By utilizing strict commit logs and access controls, the system locks down the regulatory workflow and prevents unauthorized asset manipulation.

Fragmented Knowledge

Cognitive Bottlenecks

Data Vulnerability

Zero Orphan Files via Forced Intake

Audits revealed 70% of historical files lacked FDA justifications, creating a regulatory blind spot. To fix this, I abandoned open uploads for a mandatory commit modal. By forcing female and male designers to log 21 CFR Part 11 details before saving, we eradicated undocumented assets at the source.

Workflow Architecture

Fragmented Knowledge

Cognitive Bottlenecks

Data Vulnerability

Zero Orphan Files via Forced Intake

Impact

Transitioning from reactive auditing to systemic governance

Measurable Outcomes

2 Week Results after Shipping

Measurable Outcomes

2 Week Results after Shipping

Measurable Outcomes

2 Week Results after Shipping

End-to-End Traceability

Achieved an unbroken compliance audit trail from initial R&D drafting to final FDA production.

100

End-to-End Traceability

Achieved an unbroken compliance audit trail from initial R&D drafting to final FDA production.

100

Metadata Compliance

Completely eradicated undocumented assets. Forced intake ensures no file enters without FDA justification.

100

Metadata Compliance

Completely eradicated undocumented assets. Forced intake ensures no file enters without FDA justification.

100

Cross-Functional Adoption

Successfully onboarded Regulatory Affairs, QA, and Design teams onto a single source of truth.

Cross-Functional Adoption

Successfully onboarded Regulatory Affairs, QA, and Design teams onto a single source of truth.

In medtech and enterprise UX, good design isn't just about reducing clicks, it's about engineering compliance, managing cognitive load, and mitigating systemic risk. This project reinforced my core philosophy: Sometimes, introducing friction is the most empathetic design decision you can make.

Shu, August 2023, as a takeaway.

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Roche Diagnostics — Labeling Visual Tracking System

Problem

Solution

Before

Dropbox with exclusive access to Labeling team

After

Dashboard for open cross teams access

Feature Highlight

From Dark Archive to FDA-compliant database

The Visual Diff & Audit Trail compares versions of Label

New Label Intake with mandatory FDA justification to prevent excessive orphan files

Research Findings

Qualitative audits revealed Label related pain-points

“We would routinely find 5 versions of the same label. Putting them side-by-side to figure out what changed — and why — was a compliance nightmare.”

“We would routinely find 5 versions of the same label. Putting them side-by-side to figure out what changed — and why — was a compliance nightmare.”

70%