Batch Release Hub

Project Summary

The Batch Release Hub project was a dynamic initiative aimed at reducing the batch release time and increasing the number of released batches with a single Click. With a keen focus on managing deviations in the Quality Control Department, the project sought to align with GMP regulations, simplify work, and offer a high-quality solution.

Client: Novartis

Company: SAP

Project Type: SaaS application

Project Date: 2022 -2023

My role: Senior UX Designer working with another 2 designers

Context

The client struggles with efficiency and optimisation in the laboratory and manufacturing processes while trying to move beyond the blockbuster model and deliver more therapies to more people globally at a lower cost.

The difficulty is centered around finding inventive solutions to elevate the batch release process, reducing time-to-release while maintaining and even enhancing the quality and reliability of our outputs. Participants are encouraged to think outside the conventional confines and propose strategies that push the boundaries of efficiency in our batch release operations.

The Challenge

In my ongoing pursuit of operational excellence, I was confronted with the obstacle of optimizing the batch release process. The current system, while functional, presents opportunities for improvement in both efficiency and release timelines.

The challenge at hand involved identifying innovative ways to streamline the batch release workflow, ensuring a swift and error-free process from initiation to completion. Key aspects of this challenge included minimizing bottlenecks, reducing manual intervention, and enhancing overall coordination among various stages of the release cycle.

Personas

Key Responsibilities

  • Focusing on the management of authorized activities and the accuracy and quality of records

  •  Coordinating and promptly performing any recall operations for medicinal products

  • Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place

  • Deciding on the final disposition of returned, rejected, recalled, or falsified products

  • Approving any returns to saleable stock

Storyboard

Key Responsibilities

  • Each batch of finished product must be certified by a Qualified person within the EC/EEA before being released

  • Ensuring the principles and guidelines of GMP have been followed

  • The principal manufacturing and testing processes have been validated.

  • Reviewing packaging conditions, including a review of batch records.

  • All necessary checks and tests have been performed, including any additional sampling, inspection, tests, or checks initiated because of deviations or planned changes

Problem Framing

The processing time was too high - 48 hours

I organized workshops with stakeholders, product managers, the dev team, and clients to map issues that appear most frequently in batch-release processes.

Throughout the in-depth analysis, we proposed a few solutions that were within the project scope and then prioritized them.

Process Mapping

Workflow Mapping

Work list view

After the user selects one or multiple rows, he can set the batch release process only after all deviations have been solved.

Dashboard view

The responsible person (RP) can see the day's priorities immediately and work towards the critical items.

Set Release Decision Action is safeguarded by the necessity of confirming the release with the password.

Object Page

The user can check all the parameters of a batch so he can take multiple actions

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