PSUR Workflow Automation

Summary

Overview

The PSUR workflow automation streamlined the entire drug safety tracking and compliance process, replacing slow, manual Excel tracking. Using Microsoft Power Platform integrated with SharePoint, Teams, & Outlook, SCIENS Technologies delivered a smart, automated, and transparent system that ensures accuracy, timeliness, & regulatory compliance. The system automated milestone tracking (15 drug stages), due-date calculation from the DLP, and alerts for deadlines and escalations—removing manual effort.

Key Issue

Challenge

Manual tracking through Excel sheets led to delays and frequent human errors.
Lack of real-time visibility into drug progress and milestone completions.
Inefficient coordination among teams handling review, QC, and client approvals.
Missed deadlines due to absence of automated reminders and escalations.

Our Approach

Solution

SCIENS implemented an Agentic Automation Workflow using Microsoft’s Power Platform:

PowerApps for intuitive workflow management and role-based user access.
Power Automate to manage milestone transitions, task assignments, and notifications.
Power BI dashboards for real-time analytics and compliance insights.
SharePoint a secure document repository linked with Outlook & Teams for seamless collaboration.

Client Information

Client

Largest Lifesciences Company

Domain

Pharmacovigilance

Our Case Studies

What You Get

Key Features

Drug Tracking & Access

Track drugs through milestones with real-time status. Role-based permissions for Users, Admins, and PMs

Document Workflow & Notifications

QC, Medical, &Client approvals in one flow with automated Teams/Outlook reminders.

Insights & Reporting

Dynamic dashboards and exportable reports to monitor performance, track delays, and ensure compliance in real time.

Value Created

Impact

80% reduction in manual effort and human error

Faster reporting cycles through real-time workflow visibility

Enhanced collaboration across QA, Medical and Client teams

100% regulatory compliance with automated alerts & deadlines

Result Overview

Outcome

The PSUR Workflow Automation transformed a complex, manual process into a smart, transparent, and fully automated ecosystem. By integrating data, workflows, and analytics, SCIENS enabled operational excellence in pharmacovigilance reporting, ensuring accuracy, speed, and compliance across all safety update reports.

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