Redesigning LIR & AER into a Structured, Audit-Ready Investigation Workflow

About Project

Laboratory Incident Reports (LIR) and Adverse Event Reports (AER) are critical for regulatory compliance and quality assurance in pharma.

However, the existing systems were fragmented, manual, and difficult to track leading to delays, repeated follow-ups, and compliance risk.

Seeing these inefficiencies and inspired by the success of other redesigned QMS modules (OOS, IMS), Audree initiated a redesign of the LIR and AER modules to replace fragmented, manual processes with a structured, guided digital workflow aligned with real pharma investigation practices.

Laboratory Incident Reports (LIR) and Adverse Event Reports (AER) are critical for regulatory compliance and quality assurance in pharma.

However, the existing systems were fragmented, manual, and difficult to track leading to delays, repeated follow-ups, and compliance risk.

About Project

Pharmaceutical

Team

Anush Reddy, S.Madhumala

Subscription Category

Quick win

Project start Year

August 2025

Core Business Challenges

Poor User Adoption Due to Outdated Experience

Cluttered screens and manual data entry made reporting difficult, pushing users to bypass the system and rely on emails or offline tracking.

Slowed by Process Inefficiency

Unclear steps and scattered screens made change requests hard to navigate, slowing assessments and delaying approvals.

Heavy Dependence on Manual Coordination

Lack of clear status visibility forced teams to depend on calls and follow-ups, increasing delays and operational overhead.

Heavy Dependence on Manual Coordination

Lack of clear status visibility forced teams to depend on calls and follow-ups, increasing delays and operational overhead.

Our Approach

Mapping User Flows to Uncover Hidden Gaps

We mapped the complete LIR & AER lifecycle—from event initiation and investigation to assessment, review, and closure.  This helped uncover fragmented steps, repeated data entry, missing investigation context, and unclear handoffs between laboratory, QA, and compliance teams.

Mapping User Flows to Uncover Hidden Gaps

We mapped the complete LIR & AER lifecycle—from event initiation and investigation to assessment, review, and closure. This helped uncover fragmented steps, repeated data entry, missing investigation context, and unclear handoffs between laboratory, QA, and compliance teams.

Mapping User Flows to Uncover Hidden Gaps

Designing LIR & AER Into a Structured Investigation Workflow

We transformed LIR and AER from fragmented, manual reporting into a guided, role-based workflow. Clear stages, structured inputs, and unified screens improved visibility, reduced follow-ups, and enabled faster, audit-ready investigations across teams.

LIR & AER Laboratory Event Request Initiation screen

Simplified Event Initiation for Accurate Event Reporting

We redesigned the Laboratory Event initiation flow to match how laboratory teams actually report incidents and events. Earlier, unclear fields and scattered inputs led to incomplete submissions and repeated clarifications.

The new guided digital form uses structured sections, smart validations, and grouped inputs to capture all critical details upfront ensuring accurate event reporting.

Structured Review for   LIR & AER Progression

We introduced a dedicated side navigation to clearly separate Laboratory Event and Investigation phases. This allows users to move between stages effortlessly without losing context.

Each role can instantly see what has been completed, what evidence is attached, and what actions are pending. This clear segregation and visibility reduced confusion, review delays, and unnecessary follow-ups during investigations.

We introduced a dedicated side navigation to clearly separate Laboratory Event and Investigation phases. This allows users to move between stages effortlessly without losing context.

Clear Visual Summaries for Confident Decisions

We introduced a dedicated Review Summary view that brings all critical information into one place. Impact assessments, key responses, approvals, and linked details are visually grouped for quick scanning.

Approvers can now understand the full context of an LIR or AER at a glance, make decisions faster, and proceed without navigating multiple screens or requesting clarifications.

A Cleaner UI for Faster, Confident Decisions

The redesigned UI brings clarity to every stage. Structured layouts, consistent data fields, and clear visual cues guide users smoothly through the workflow without confusion or backtracking

Results That Redefined LIR & AER Investigation Lifecycle

Clearer workflows, phase-wise investigations, and guided role-based actions transformed how laboratory incidents and adverse events are reported, reviewed, and closed.

Stronger Compliance & Traceability

Real-time visibility, structured phase-wise documentation, and controlled inputs ensured every incident detail, assessment, and action was captured accurately. This reduced compliance gaps, strengthened audit readiness.

Faster API Batch Execution

Guided digital steps replaced scattered documents and manual coordination, enabling faster reporting, investigation, and approvals with clear instructions and linked evidence.

Fewer Support Tickets

Unified screens, clear status visibility, and a continuous investigation flow eliminated confusion and backtracking. All updates are visible in one place, reducing follow-ups and dependency on support teams.

Faster API Batch Execution

Guided digital steps replaced scattered documents and manual coordination, enabling faster reporting, investigation, and approvals with clear instructions and linked evidence.