Reducing batch release time
from 48 hours to a
single click.
A UX design project for Novartis × SAP — redesigning the Batch Release Hub to eliminate manual bottlenecks, enforce GMP compliance, and give Qualified Persons the confidence to release with certainty, not anxiety.
Pharma batch release is
where speed and compliance collide.
Every pharmaceutical batch must pass through a rigorous quality control and release process before it can be distributed. At Novartis, that process was taking up to 48 hours — not because the science required it, but because the software made it hard. Manual steps, disconnected data, and a system that didn't reflect how people actually worked were costing time that translated directly into delayed therapies reaching patients.
- Batch release processing time: 48 hours — too slow for operational targets
- High manual intervention throughout the release workflow
- Deviation management in QC was fragmented and hard to track
- No consolidated dashboard for daily priority management
- Release decisions required navigating multiple disconnected screens
- Error risk was high — with regulatory consequences for any mistake
Senior UX Designer on a team of three, working embedded within the SAP–Novartis project. Led user research with QC laboratory and manufacturing stakeholders, facilitated problem framing workshops with product managers and dev teams, designed and iterated on the core user flows, and validated through multiple rounds of testing with the actual Responsible Persons and Qualified Persons who would use the system daily.
Design a SaaS application that reduces time-to-release while maintaining — and enhancing — quality and reliability. The system needed to support compliance with EU GMP regulations, not work around them. Every UX decision had a regulatory dimension. Speed without safety was not the goal.
Designing inside
a regulated environment.
This wasn't a consumer app where we could move fast and iterate. Every design decision existed within three intersecting constraint layers — regulatory, operational, and human. Understanding all three was the prerequisite for designing anything useful.
Two roles. Different needs.
One shared pressure.
The Batch Release Hub served two primary users with distinct responsibilities but a shared goal: getting safe, compliant batches released as quickly as possible. Designing for both required understanding where their workflows diverged — and where they depended on each other.
- Accuracy and quality of all batch records
- Coordinating recall operations for medicinal products
- Ensuring self-inspections follow a prearranged program
- Final disposition of returned, rejected, or recalled products
- Approving returns to saleable stock
- Certifying every batch of finished product before EC/EEA release
- Verifying GMP principles have been followed throughout manufacturing
- Confirming principal manufacturing and testing processes were validated
- Reviewing packaging conditions and batch records
- Ensuring all checks and tests completed — including deviation-triggered extras
The RP needs a priority-driven dashboard that surfaces what needs attention today without requiring a manual triage of every batch. The QP needs complete, consolidated batch information on a single screen — because their certification decision requires confidence that nothing has been missed. These two needs shaped the entire information architecture.
Where the 48 hours
were actually going.
Stakeholder workshops with product managers, the dev team, and Novartis clients mapped where time and errors accumulated in the existing process. The bottlenecks weren't random — they were structural, and they repeated across every batch cycle.
No Consolidated Priority View
RPs had no single view of what needed attention today. Determining daily priorities required manually checking multiple sources — introducing delay before any actual work began.
Deviation Blocking Without Visibility
Batches with open deviations couldn't be released — but the system didn't surface which deviations were blocking which batches, or their resolution status. Users had to investigate manually.
Multi-Screen Parameter Review
QPs needed to review all batch parameters before certifying. This required navigating multiple screens and cross-referencing data manually — a time-intensive process with significant error surface.
Bulk Release Not Supported
Releasing multiple compliant batches required repeated individual actions. No mechanism existed to select and release multiple batches simultaneously — even when all preconditions were met.
Release Confirmation Friction
The password-confirmation step required by GMP regulation needed careful UX handling — too much friction would invite workarounds; too little would undermine the compliance purpose of the step.
Four flows. Each solving
a specific bottleneck.
Solutions were scoped and prioritised in workshops — evaluated against feasibility, compliance requirements, and impact on release time. Every solution had to work within the SAP design system and GMP constraints.
Surface today's critical batches immediately on login
The Responsible Person's dashboard was redesigned to show daily priorities at a glance — critical items flagged by urgency, deviation status visible inline, and actionable tasks surfaced without any manual triage. The RP sees what matters most before touching anything else.
This intervention targeted the very first step of the daily workflow — where delay accumulated before any release work had even begun.
Make deviation status visible — and release impossible until it's resolved
The work list view was redesigned so users can see, at a glance, which batches have open deviations and what those deviations are. The release action is gated: a batch cannot enter the release process until all deviations are resolved. The system enforces the rule — the user doesn't have to remember it.
This eliminated a class of errors where batches with unresolved deviations were accidentally progressed — a compliance risk that manual processes couldn't reliably prevent.
All batch parameters on one screen — so the QP can certify with confidence
The Object Page consolidates every parameter a Qualified Person needs to review before release: batch records, testing results, packaging conditions, deviation history, and GMP validation status — all accessible without navigating away. Multiple actions are available from a single view.
The design goal was to reduce the cognitive load of the certification decision. A QP who has to jump between screens to assemble a complete picture is a QP who may miss something. The consolidated Object Page makes the complete picture the default.
Select multiple. Release once. With a confirmation that means something.
Users can now select multiple rows in the work list and initiate batch release for all of them simultaneously — provided all deviations are resolved. The bulk release path removes the repetitive single-action loop that multiplied processing time with every batch.
The password confirmation step — a GMP requirement — was redesigned to be clear and frictionless without being dismissible. The confirmation dialog makes the weight of the action legible. Users know they're signing something that matters.
From workshop
to validated workflow.
The design process was structured around the complexity of the domain. No assumption about user behaviour survived contact with actual QPs and RPs. Every major design decision went back to the people who would have to live with it.
Stakeholder Workshops — Problem Framing
Cross-functional workshops with PMs, dev team, and Novartis clients to map the most frequent issues in the batch release process. Output: a prioritised list of friction points within project scope.
Process & Workflow Mapping
Detailed mapping of the existing batch release process — identifying handoffs, decision points, waiting states, and where deviations entered the flow. Gave the team a shared model of what they were redesigning.
Persona Development & Storyboarding
Built detailed RP and QP personas grounded in stakeholder interviews. Created storyboards for each persona's daily workflow to identify where the designed solution needed to intersect with real working patterns.
Solution Design & Prioritisation
Generated solution candidates in workshops, then scored and prioritised against impact, feasibility, and compliance constraints. Applied the SAP Fiori design system throughout to ensure platform consistency and accessibility.
Prototyping, Testing & Iteration
High-fidelity prototypes validated with actual RPs and QPs. Iterated on information hierarchy, action placement, and confirmation UX based on observed behaviour — not assumed preferences.
UX in regulated domains
is a different discipline.
Designing for a GMP-regulated pharma environment stretched every UX principle to its limit. The stakes were different. The constraints were harder. And the users had no patience for anything that made an already demanding job more complicated.
Compliance by design beats compliance by reminder. The most important UX decision in this project wasn't visual — it was architectural. By making deviation resolution a hard gate on the release action, we removed an entire class of human error. The system enforced the rule so the user didn't have to remember it under pressure.
Expert users have zero tolerance for unnecessary friction. RPs and QPs are domain experts working under time pressure with high stakes. Every extra click, every ambiguous status, every screen navigation that required mental mapping was costing them time they didn't have. The design bar in enterprise expert tools is actually higher than in consumer products — the users just can't switch to a competitor.
The confirmation step is a design opportunity, not a compliance tax. The GMP-required password confirmation on batch release could have been implemented as a generic modal. Instead, we designed it to make the weight of the action legible — so users felt the significance of what they were certifying, not just the inconvenience. A meaningful confirmation step is better UX and better compliance.
Workshop facilitation is a design skill. The problem framing and prioritisation workshops were as important as any screen I designed. Getting PMs, developers, compliance officers, and end users to build a shared model of the problem — and agree on what to solve first — was the work that made the design work possible.
Process mapping and UX design are the same thing in a different register. Understanding the batch release process at the workflow level was a prerequisite for designing anything useful at the screen level. In complex enterprise contexts, you can't design the interface before you understand the process. They're the same problem viewed at different scales.
A batch release system that
works the way experts work.
From 48-hour manual process to a system where a compliant batch can be released in a single, safeguarded action. Two personas. Four core design interventions. One year of embedded design in a GMP-regulated enterprise environment.
This project mattered because the output wasn't a screen — it was a faster path to medicine reaching patients. Every hour saved in the batch release process is an hour gained in therapy availability. Designing in pharma is a reminder that UX is never just UX. The quality of the interface is inseparable from the quality of the outcome it enables.
Need UX design for
complex enterprise systems?
Regulated environments, expert users, high-stakes decisions — the harder the constraint, the more design matters. Let's talk about what you're building.