Redesigning CAPA Execution Into Traceable, Compliant Workflow

About Project

Corrective and Preventive Action (CAPA) is a critical quality process in pharma, used to identify root causes, define corrective actions, track effectiveness, and prevent recurrence of deviations. Existing CAPA system was fragmented, manual, and difficult to track leading to delays, follow-ups, and audit risk.

Audree wanted to redesign the CAPA module into a structured, guided digital workflow that aligns with real QA practices, reduces manual effort, and ensures end-to-end traceability from initiation to closure.

About Project

Pharmaceutical

Team

S.Madhumala, Kishore

Subscription Category

Quick win

Project start Year

August 2024

Core Business Challenges

Poor User Adoption Due to Outdated Experience

Cluttered UI and unclear flows pushed users to rely on emails, spreadsheets, and offline tracking instead of the system.

Slowed by Process Inefficiency

Frequent support tickets arose from repetitive entry, scattered steps, and unclear stages slowing a process that must stay fast and compliant.

Heavy Dependence on Manual Coordination

Lack of real-time status visibility led to repeated follow-ups between QA, production, and management teams.

Heavy Dependence on Manual Coordination

Lack of real-time status visibility led to repeated follow-ups between QA, production, and management teams.

Our Approach

Mapping User Flows to Uncover Hidden Gaps

We mapped the complete CAPA lifecycle from initiation and root cause analysis to action implementation, effectiveness checks, and closure to identify where actions stalled, repeated, or lost context.

Mapping User Flows to Uncover Hidden Gaps

We mapped the complete CAPA lifecycle from initiation and root cause analysis to action implementation, effectiveness checks, and closure to identify where actions stalled, repeated, or lost context.

Mapping User Flows to Uncover Hidden Gaps

We mapped the complete CAPA lifecycle from initiation and root cause analysis to action implementation, effectiveness checks, and closure to identify where actions stalled, repeated, or lost context.

Designing CAPA Into a Guided Workflow

The CAPA process was transformed into a single, guided workflow with clear, role-based stages from initiation to closure. Unified screens and phase visibility eliminated manual tracking and follow-ups, enabling faster resolution, stronger compliance, and confident execution across QA and operations.

CAPA action workflow management dashboard

Streamlined CAPA Initiation for Faster Resolution

We redesigned CAPA initiation to reflect how issues are actually identified and assessed on the shop floor and in QA. Critical details, root cause context, and supporting evidence are captured upfront in a structured format, ensuring clean handovers and faster action planning.

Clear inputs and early validations reduce back-and-forth and help teams start CAPAs with complete, reliable information.

Structured Workflow for CAPA Execution

The CAPA workflow became a clear, step-by-step flow from planning to closure, removing reliance on scattered records and manual tracking.

Each role can clearly see

Completed actions and supporting evidence
Pending responsibilities and approvals
Current status and next steps

This turns CAPA from a reactive task into a predictable, controlled workflow.

The CAPA workflow became a clear, step-by-step flow from planning to closure, removing reliance on scattered records and manual tracking.

Each role can clearly see

Completed actions and supporting evidence
Pending responsibilities and approvals
Current status and next steps

This turns CAPA from a reactive task into a predictable, controlled workflow.

The CAPA workflow became a clear, step-by-step flow from planning to closure, removing reliance on scattered records and manual tracking.

Each role can clearly see

Completed actions and supporting evidence
Pending responsibilities and approvals
Current status and next steps

This turns CAPA from a reactive task into a predictable, controlled workflow.

CAPA execution workflow progress interface

Clear Visual Guidance for Controlled CAPA Execution

Clear workflow indicators and role-based actions guide CAPA execution, making progress, ownership, and next steps easy to understand at every stage.

Structured UI for Smarter, Error-Free CAPA Execution

The redesigned CAPA UI uses clear layouts and visual cues to guide each stage, reducing errors and keeping teams aligned without manual follow-ups.

Result That Redefined Investigation Lifecycle

Clearer CAPA workflows, connected action stages, and structured role-based responsibilities improved execution speed, reduced rework, and strengthened compliance across QA and operational teams.

Stronger Compliance & Traceability

Clear step-by-step workflows, role-based actions, and a structured digital flow transformed CAPA from a fragmented process into a controlled, audit-ready lifecycle.