Smarter Review & Approval Workflow for Pharma Validation
In the Pharma & Life Sciences industries, configuring reviewers and approvers is a crucial step in the validation process. However, traditional methods often lead to inefficiencies, miscommunication, and compliance risks.
To solve this, we designed a Workflow Component that:
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Allows intuitive configuration of reviewers & approvers based on roles, hierarchy, and project needs.
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Ensures seamless tracking & approval management with automated notifications and status updates.
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Stores approval records securely for future validation and compliance audits.
This user-centered design streamlines the validation process, ensuring efficiency, traceability, and regulatory compliance
Background
Validation plays a major role in Pharma and Life sciences industries. Each step in the manufacturing process is thoroughly validated and then carried forward to the next step. Now what is validation ? Validation is nothing but to get the document that captures the details of the process so it should be checked by someone who may be an expert of that process or domain and get it validated on the accuracy and process it to the next step.
Since I had not gone through the product training as I wasn't even sure about the product and its need but I was told that it was a generic component one may not require prior product knowledge but none shared the significance of the component.
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What is workflow ?
Workflow is a common component in one of the prime applications that involves a list of Reviewers and Approvers created in a structured flow assigned in a logical order.
Requirements / Expectations
Received a requirement doc from the product team. Product team is clear that they wanted to bring the Workflow component in a diagrammatic representation unlike the robotic approach having forms to tag users in previous applications. It’s a good leap from the product end to bring canvas in this case. User stories were shared with some screenshots from old applications. But while i was reading them, somehow i was influenced by the write ups.
Below are the examples of few main user stories with Acceptance criteria:
AC1 : As a user, they can able to drag and drop the users on the canvas
AC2 : User can assign each user as Reviewer or Approver
AC3 : User can arrange a sequence of Reviewers or Approvers in either series or parallel.
Initial Pain Points
Point 1 : User stories and the Acceptance criteria which was shared considering the majority of the Design decisions taken by product that left with almost no scope for any ideation as a Designer other than just following user stories and delivering the designs to them.
Point 2 : Spoke to my Design teammates about the internal process and expectations and i was told that I shouldn't miss anything from the Acceptance criteria which is understandable. But when i question about user stories my team replied yes this is how we receive requirements then we design accordingly with no deviations to it and the same exchange is happening between Product and Design team since 2019 (more than 3.5years)
Point 3 : It was easy for me if I had followed the same process but I was really unsure to just follow based on what the product asked for and I was not even sure if I could try any new approach to achieve the same.
Point 4 : I was not completely aware of team dynamics, whether they will be receptable or no.
Point 5 : Also learnt that the UX Maturity within the organisation is Absent.
Research
Started digging for more information only to understand the existence of this component called Workflow in our system. Below are some very basic questions that were running through my mind.
Who creates this component?
Why do they create?
How frequently do they create?
Since this company is at the mid level, it was easier to reach out to the people not just the product team but other customer facing teams to know more about the users who are using this component in real time. Like said this component is an existing component in old applications but it was created like a form where the user selects using a dropdown in each row. But the current requirement is for the latest platform adopting a canvas layout. So I tried interviewing the customer facing teams to gather some insights.
Key Takeaways from Research
Takeaway 1 : This is the most frequently used component in the system and is used across all the modules in platform
Takeaway 2 : This component was created by an admin, who was not that much familiar with Canvas layouts. They must have used canvas occasionally unless their interests are into Art.
Takeaway 3 : As this is a frequently used component, drag and drop elements on canvas to establish a flow would also be challenging for a user. Because users in workflow can go to any limit.
Takeaway 4 : Admin will create a workflow under components, Document authors will author documents and tag any workflow to it. All the users who are involved in Workflow will be notified to perform the required tasks on document tagged.
Takeaway 5 : User can also create workflows with different combinations. Workflows with Reviewers and Approvers but for some documents Reviewers are not needed so it will just be Approvers. So Reviewers are going to be optional but Approvers are mandatory to configure
Takeaway 6 : There are high chances of coming back to modify the existing flow
Takeaway 7 : There are chances where the same set of users can be both as Reviewers and Approvers.
Proposal
Instead of not deviating completely from canvas approach, proposed a solution on Template based Design pattern. Also research supported that admin who creates workflow are not comfortable dragging and dropping every element on canvas and then connecting nodes followed by tagging roles to it. It is a robust process that too for a most frequently used component.
Came up with a solution having a standard default template on the canvas with one reviewer and one approver cards on canvas, on click of reviewer card a panel gets opened with the list of users or groups and also sees also Add icons enabled in selected state and helps user to add another reviewer in series or parallel.
Below is the example of a flow when a admin tries creating a workflow by adding 2 Reviewers in Parallel and 1 in Series and later deletes two Reviewers and configures 1 Approver.
Reasons that supports current proposal
Reason 1 : Reduces the effort of Drag and Drop
Reason 2 : Saves lot of time to create even larger workflows
Reason 3 : Though it is on canvas, the system is guiding a user in a structured manner by limiting the features on it instead allowing a free ground to play around in canvas to establish a flow.
Reason 4 : Can make use of many assistive features that were proposed.
Reason 5: Can help user to have their own personalised view
How did i convince the stakeholders ?
This is probably the first time that Design team had deviated from requirements i first went to my manager and shown this approach and he was happy as i said as it's just one rough approach but my manager said let’s take this to stakeholder demo by just showcasing our initial ideas then I got into a demo with my CEO and Product heads so explained that we are working on this task and we just came up with this approach and it has many advantages. So we thought we could show at this stage only to get the early feedback.
I started to share my screen with a working prototype of the first draft and also explaining the advantages by using this template based approach so the user doesn’t have to learn more on the feature as the system itself is going to do half of the user's job.
There was complete silence in the meeting for around 2-3 minutes after my demo, later I heard a voice from my Product Head asking a query on How can a user delete a reviewer or approver in this approach? I showed the same using a wireframe. Again 1 minute of silence.
Atlast, we received a reply from Product Head stating “Let’s go ahead with this approach and you continue doing it so we can reconvene next week to see the progress”
That’s how it all started…
Assistive Features
* Admin can disable the switch of Reviewers if there is no need for any documents
* Admin can make use of Screen rotation to have a personalised view for the sequence
* Admin can make use of Zoom In / Out based on the size
* Admin can make use of Copy feature to copy list of reviewers to approvers and vice versa so that it reduces time to do duplicate selections
* Admin can also hide reviewers and reduce scroll effort for larger workflows
* Admin can make use of the existing workflows and save as template and later can come back to make use of templates instead doing everything from scratch.
* Admin can make use of + icon to Add new item based on the direction of icon
* Admin can also drag and change the sequence of the Reviewer or Approver group
Impact in the Organisation
Product team and Engineering used to consider and treat Design team as just the Designers who just paints and draws based on product requirements. Design team will just beautify the screens and add more colours to it and make them appealing.
This particular task has created some kind of controversy within the organisation as for the first time there was a new design proposed by completely deviating from the user stories. But my product head never said anything to me directly based on the finalised approach. He also started to contribute 1-2 additional features to it.
From then, there was a complete openness from the product end (at least for me) on ideating any requirement. Product team also changed the pattern in writing the user stories. There was a strict rule passed from the Design team that User stories should not involve any Design decisions.
Design decisions should be solely done by the Designers but not the Product.
User Testing
Testing was conducted with a sample size of 10 users who are mostly internal users working as various department leads. Sent an invite to all 10 users and blocked their calendars 30-45 mins from each user.
We have prepared some set of questions and tasks to perform. So we synced up with the participants on the team's call and asked them to go through the first page of the prototype without clicking anywhere and ask their opinions on every element that they see. We ended up recording the entire conversation.
When they started we noticed users were clueless what to do and kind of frustrated. Later we brought the introductory text as part of the mockup. So 6 users were quick enough to adopt the proposed design as they took some time to accept and get used to the flow and ultimately they were happy in the end. User also said this may look new and unusual for us to create a workflow but as we start using it i think we feel this is the most simplest way to create a workflow.
7 users - Initially were clueless but they din't took much time to get used to it. Final verdict is Happy
3 users - Neutral (Takes time to learn about it)
UX Maturity
My department head and me prepared a questionnaire and did an internal survey to know the understandings and dynamics of UX team within the organization. We have first conducted a survey in last November'23 as we felt it was almost Absent. Later we have re-conducted the survey this June'24 (after 6months). Current UX maturity of the company is Emerging.