Redesigning OOS Investigations Into a Clear, Compliant Workflow
Redesigning OOS Investigations Into a Clear, Compliant Workflow
Redesigning OOS Investigations Into a Clear, Compliant Workflow
About Project
About Project
About Project
Out of Specification (OOS) events occur when laboratory test results fall outside approved limits triggering a structured investigation to identify root causes and confirm product quality.
Audree wanted to redesign their OOS module because the existing system was difficult to use: investigations were scattered across multiple screens, documentation was manual and inconsistent, and teams (QA, QC, Production) struggled with repeated back-and-forth during Extended Lab Investigations.
The goal was to turn this complex, multi-stage investigation into one guided, predictable digital workflow. We redesigned the entire OOS lifecycle from initiation, preliminary checks to final QA disposition into a structured, compliant flow that mirrors how investigations happen on ground.
Out of Specification (OOS) events occur when laboratory test results fall outside approved limits triggering a structured investigation to identify root causes and confirm product quality.
Audree wanted to redesign their OOS module because the existing system was difficult to use: investigations were scattered across multiple screens, documentation was manual and inconsistent, and teams (QA, QC, Production) struggled with repeated back-and-forth during Extended Lab Investigations.
The goal was to turn this complex, multi-stage investigation into one guided, predictable digital workflow. We redesigned the entire OOS lifecycle from initiation, preliminary checks to final QA disposition into a structured, compliant flow that mirrors how investigations happen on ground.
About Project
Pharmaceutical
Team
T.Srinivas, S.Madhumala
Subscription Category
Quick win
Project start Year
August 2025
Core Business Challenges
Core Business Challenges
Core Business Challenges
Poor User Adoption Due to Outdated Experience
Poor User Adoption Due to Outdated Experience
Poor User Adoption Due to Outdated Experience
The outdated UI and unclear lifecycle made teams cross-check data constantly just to understand where an API batch stood.
The outdated UI and unclear lifecycle made teams cross-check data constantly just to understand where an API batch stood.
The outdated UI and unclear lifecycle made teams cross-check data constantly just to understand where an API batch stood.
Slowed by Process Inefficiency
Slowed by Process Inefficiency
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.
Frequent support tickets arose from repetitive entry, scattered steps, and unclear stages slowing a process that must stay fast and compliant.
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
Heavy Dependence on Manual Coordination
Teams depended on calls and offline checks to validate updates slowing approvals and increasing QA & Production workload.
Teams depended on calls and offline checks to validate updates slowing approvals and increasing QA & Production workload.
Heavy Dependence on Manual Coordination
Teams depended on calls and offline checks to validate updates slowing approvals and increasing QA & Production workload.
Our Approach
Our Approach
Our Approach
Mapping User Flows to Uncover Hidden Gaps
We mapped the entire OOS lifecycle from initiation to final QA disposition to uncover where teams were stuck, repeating steps, or losing information across Phases and Extended Lab Investigation.
Mapping User Flows to Uncover Hidden Gaps
We mapped the entire OOS lifecycle from initiation to final QA disposition to uncover where teams were stuck, repeating steps, or losing information across Phases and Extended Lab Investigation.
Mapping User Flows to Uncover Hidden Gaps
We mapped the entire OOS lifecycle from initiation to final QA disposition to uncover where teams were stuck, repeating steps, or losing information across Phases and Extended Lab Investigation.
Designing Investigation Into a Guided Workflow
Designing Investigation Into a Guided Workflow
Designing Investigation Into a Guided Workflow
We rebuilt the OOS investigation process by turning a complex, multi-stage sequence into one structured, guided workflow. Each phase was reorganised into predictable, role-based steps with clear investigation cues. With unified screens, stage visibility, and consistent documentation, teams no longer move between scattered information, repeated returns, or unclear investigation loops.
We rebuilt the OOS investigation process by turning a complex, multi-stage sequence into one structured, guided workflow. Each phase was reorganised into predictable, role-based steps with clear investigation cues. With unified screens, stage visibility, and consistent documentation, teams no longer move between scattered information, repeated returns, or unclear investigation loops.
Streamlined OOS Initiation for Faster, Investigations
Streamlined OOS Initiation for Faster, Investigations
Streamlined OOS Initiation for Faster, Investigations
We reworked the OOS initiation flow to match how QC analysts actually report and validate out-of-spec results. Critical details, attachments, and test parameters are captured in a structured format, ensuring cleaner handovers from QC to QA.
Clearer forms, guided inputs, and upfront validation checks reduce back-and-forth and help teams start investigations with complete, reliable data.
We reworked the OOS initiation flow to match how QC analysts actually report and validate out-of-spec results. Critical details, attachments, and test parameters are captured in a structured format, ensuring cleaner handovers from QC to QA.
Clearer forms, guided inputs, and upfront validation checks reduce back-and-forth and help teams start investigations with complete, reliable data.
We reworked the OOS initiation flow to match how QC analysts actually report and validate out-of-spec results. Critical details, attachments, and test parameters are captured in a structured format, ensuring cleaner handovers from QC to QA.
Clearer forms, guided inputs, and upfront validation checks reduce back-and-forth and help teams start investigations with complete, reliable data.
Structured Phases for Seamless Investigation
Structured Phases for Seamless Investigation
Structured Phases for Seamless Investigation
We redesigned the OOS screen with a clean phase-wise navigation, making every step of investigation easy to find without searching.
Each role can clearly see
What was completed in earlier steps, along with evidence, comments, and any extensions.
With top progress indicators and neatly separated actions.
where the investigation stands
what comes next
Turning a previously scattered process into a simple, predictable workflow.
We redesigned the OOS screen with a clean phase-wise navigation, making every step of investigation easy to find without searching.
Each role can clearly see
What was completed in earlier steps, along with evidence, comments, and any extensions.
With top progress indicators and neatly separated actions.
where the investigation stands
what comes next
Turning a previously scattered process into a simple, predictable workflow.
We redesigned the OOS screen with a clean phase-wise navigation, making every step of investigation easy to find without searching.
Each role can clearly see
What was completed in earlier steps, along with evidence, comments, and any extensions.
With top progress indicators and neatly separated actions.
where the investigation stands
what comes next
Turning a previously scattered process into a simple, predictable workflow.
Visual Cues That Make Investigations Effortless
Visual Cues That Make Investigations Effortless
Visual Cues That Make Investigations Effortless
Status tags, trend insights, and structured phases turn complex OOS investigations into clear, actionable steps. Users instantly see progress and next actions removing confusion.
Status tags, trend insights, and structured phases turn complex OOS investigations into clear, actionable steps. Users instantly see progress and next actions removing confusion.
Structured UI for Smarter, Error-Free Investigations
Structured UI for Smarter, Error-Free Investigations
Structured UI for Smarter, Error-Free Investigations
The redesigned UI makes every step easy to follow clean layouts, structured tables, and clear visual cues help users act confidently, avoid mistakes, and stay aligned across QA, QC, and Production.
The redesigned UI makes every step easy to follow clean layouts, structured tables, and clear visual cues help users act confidently, avoid mistakes, and stay aligned across QA, QC, and Production.
Result That Redefined Investigation Lifecycle
Result That Redefined Investigation Lifecycle
Result That Redefined Investigation Lifecycle
Defined CAPA workflows with role-based actions and controlled reviews improved closure predictability, reduced deviations, and strengthened audit readiness across teams.
Defined CAPA workflows with role-based actions and controlled reviews improved closure predictability, reduced deviations, and strengthened audit readiness across teams.
Stronger Compliance & Traceability
Stronger Compliance & Traceability
Stronger Compliance & Traceability
Real-time visibility and structured, phase-wise documentation ensured accurate capture of every action, reducing compliance gaps and improving audit readiness.
Real-time visibility and structured, phase-wise documentation ensured accurate capture of every action, reducing compliance gaps and improving audit readiness.
Real-time visibility and structured, phase-wise documentation ensured accurate capture of every action, reducing compliance gaps and improving audit readiness.
Faster API Batch Execution
Guided digital steps replaced scattered documents and manual coordination, enabling faster investigations with clear instructions and auto-linked evidence.
Fewer Support Tickets
Unified screens and clear status visibility reduced confusion and support dependency, with every investigation detail visible in one continuous flow.
Faster API Batch Execution
Faster API Batch Execution
Guided digital steps replaced scattered documents and manual coordination, enabling faster investigations with clear instructions and auto-linked evidence.
Guided digital steps replaced scattered documents and manual coordination, enabling faster investigations with clear instructions and auto-linked evidence.
Fewer Support Tickets
Fewer Support Tickets
Unified screens and clear status visibility reduced confusion and support dependency, with every investigation detail visible in one continuous flow.
Unified screens and clear status visibility reduced confusion and support dependency, with every investigation detail visible in one continuous flow.
Deep-Dive Into More System
Deep-Dive Into More System
Deep-Dive Into More System
Browse every optimised Software and explore how legacy systems became intuitive.
Browse every optimised Software and explore how legacy systems became intuitive.
Browse every optimised Software and explore how legacy systems became intuitive.
RCAI
Root Cause Analysis with Intelligence
LMS
Learning Management System
LIMS
Laboratory Information Management System
S & OP
Sales & Operations Planning
E-BMR
Batch Manufacturing Recall
WMPS
Warehouse Management System
DMS
Document Management System
CAPA
Corrective And Preventive Actions
QAS
Quality Agreement System
Vendor Portal
Vendor Management System
LIR-AER
Laboratory Information Record
OOS
Out Of Specification
CMS
Change Management System
IMS
Incident Management System
BRMS-API
Batch Record- Active Pharmaceutical Ingredient
E-BRMS
Batch Record Management System
RIMS
Regulatory Information Management System
APQR
Annual Product Quality Review
RCAI
Root Cause Analysis with Intelligence
LMS
Learning Management System
LIMS
Laboratory Information Management System
S & OP
Sales & Operations Planning
E-BMR
Batch Manufacturing Recall
RIMS
Regulatory Information Management Systems
IMS
Incident Management System
BRMS-API
Batch Record- Active Pharmaceutical Ingredient
E-BRMS
Batch Record Management System
APQR
Annual Product Quality Review
RIMS
Regulatory Information Management System
WMPS
Warehouse Management System
DMS
Document Management System
CMS
Change Management System
OOS
Out Of Specification
LIR-AER
Laboratory Information Record
Vendor Portal
Vendor Management System
QAS
Quality Agreement System
CAPA
Corrective And Preventive Actions