Regulated ITSM for Life Sciences
Business Problem
Traditional ITSM platforms struggle to handle the rigor of GxP requirements. Change requests often require dual entry into both ServiceNow and Quality Management Systems (QMS), leading to inefficiencies, delays, and audit risks. Quality and IT teams are siloed, making collaboration on deviations, CAPAs, and change controls time-consuming and error-prone.
At the same time, validation processes slow release cycles and drain resources.
With the pace of digital transformation accelerating, organizations need a more intelligent, streamlined, and compliant solution.
• AI-AUGMENTED, COMPLIANCE-FIRST STRATEGY TO UNIFY IT AND QUALITY
The USDM Approach
USDM Life Sciences addresses these challenges through an AI-augmented, compliance-first strategy that connects IT and Quality using a unified ServiceNow platform.
ServiceNow Products Supported
• ACCELERATE ITSM WITH AI-DRIVEN SDLC AND REGULATED RELEASE MANAGEMENT
ITSM for Life Sciences
Accelerate your IT service delivery with automated Software Development Lifecycle (SDLC), Agentic Artificial Intelligence (AI), and optimized impact assessment. USDM aligns IT Service Management (ITSM) with Configuration Management Database (CMDB) assessments and the Common Service Data Model (CSDM) for improved visibility and smarter release cycles—perfectly suited for regulated environments.
• INTELLIGENT, COMPLIANT, AND VALIDATED WORKFLOWS FOR GxP AND NON-GxP OPERATIONS
Key Capabilities
Unified Workflows Across IT and Quality using ProcessX and Agentic AI, USDM enables seamless, intelligent triage of service requests, incidents, and change controls. AI classifies the GxP relevance of each ticket and routes it appropriately—ensuring the right stakeholders are engaged and compliance actions are triggered automatically.
Segregated GxP and Non-GxP Flows ProcessX allows companies to maintain a single ServiceNow instance while keeping GxP workflows in a validated boundary. This segregation enables companies to innovate rapidly on non-GxP processes while maintaining tight control over regulated workflows.
CSA-Aligned Validation USDM pioneered CSA practices and builds automated validation directly into the ServiceNow workflow. Validation Lifecycle Management (VLM) in ProcessX simplifies system onboarding, change control, and system retirement—all with FDA-trusted audit trails.
CMDB & CSDM Strategy for Accuracy a well-structured CMDB and CSDM are critical for service visibility and impact analysis. USDM helps clients implement these frameworks specifically for GxP environments, boosting accuracy and enabling faster root-cause analysis.
Expected Business Outcomes
Partnering with USDM unlocks measurable improvements across IT and Quality teams:
50% faster approval of CAPAs and Change Requests thanks to intelligent routing and approval automation.
30% reduction in overdue deviations by centralizing data and embedding compliance workflows into ITSM.
100% traceability across lifecycle activities from validation to deployment with automated test and audit artifacts.
30% shorter release cycles through CSA-aligned validation, built-in automation, and reduced manual testing.
Why USDM?
Pre-validated workflows for Change Control, Incident Management, Periodic Review, and User Access
CSA-aligned validation practices approved by FDA auditors
ProcessX VLM with automated test generation and traceability matrix
Seamless integration with Veeva, SAP, and other regulated systems
We reduced our IT change approval cycle from 70 days to
just under 21—and we’re on track to reach sub-10 days with AI. The compliance and collaboration improvements have been enormous.