Case Studies

Life Science Implementation

Transforming IT Operations in Life Sciences with ServiceNow ITSM for Enhanced Efficiency and Compliance.

Requirements

• Streamline handling of IT issues

• Align service request process that meet industry regulations

• Controlled deployment and release of IT issues

• Visibility into IT performance and compliance status.

Solution

• Workflows that align with FDA, HIPAA regulations, ensuring validation specific to life-science process

• Core ITSM modules, including Incident management, Problem management, change management tailored to meet life-science compliance needs.

• Solution integrating ServiceNow ITSM with ERP and clinical trial systems for seamless data flow

• Change Advisory Board with controlled change management and approval process

• Controlled change approval processes with electronic approval and validation checkpoints to ensure governance in change management process

• Service Level management process based in SLAs including SLA policies, SLA breach notification and automated escalation

• Real-time dashboards to monitor status, tracking SLAs, and monitor trend analysis of various types of tickets (i.e. incident, problem, and change)

• User training on the modules developed

Technology

• ServiceNow ITSM

Life Science Implementation

Ensuring compliance, audit trails, and process automation for FDA-regulated products by integrating ServiceNow with an ERP system. This integration facilitates Bill of Materials (BoM) management, streamlining compliance workflows in the Life Sciences industry to meet FDA regulations.

Requirements

• FDA Regulatory Compliance: Ensuring FDA compliance requires strict audit controls and validation processes.

• Maintaining Approvals & Audits: Real-time reporting and approvals details with audit information, quicker overall processes.

• Improved Change Management: Bill of Materials (BoM) updates required multiple approvals will need automated workflow solution.

• Sync between Systems: Synchronization of data between ServiceNow is key to avoid manual data transfers, eliminate manual errors and compliance risks.

• Enhanced Visibility: Enable stakeholders to track to-do list, approvals, change history, maintenance records related to regulated items.

Solution

• Integration of ServiceNow request management with ERP BoM module using Service Integration Hub to enable real-time updates of BoM details, multi-level approvals by implementing ServiceNow workflows that is aligned with FDA guidelines.

• Managing electronic signatures and audit trails to comply with FDA compliance guidelines by capturing electronic signatures, access control, and automated audit logs in ServiceNow.

• Integrate ServiceNow with ERP to track asset and maintenance modules, ensuring regulatory compliance for equipment calibration and servicing.

• Implementation of core GRC modules including Incident management, Problem management, Request management tailored to meet life-science compliance needs.

• Real-time monitoring of status, tracking SLAs, dashboards, and trends of different GRC requests.

• Configuration of ServiceNow dashboards for Regulatory Reporting and automated reports to facilitate FDA audits, deviation tracking, and compliance documentation.

• Service Level management process based in SLAs including SLA policies, SLA breach notification and automated escalation

• Integrate ServiceNow GRC and ITSM with ERP to streamline issue tracking, resolution, and root cause analysis for quality teams.

• User training on the modules implemented for smooth adoption, enhance productivity, and enable members to effective utilization of features

Technology

• ServiceNow GRC, ServiceNow Integration Hub

Key Objectives

• Electronic record control of BoM data changes

• Data change approvals and audits are stored securely and cannot be altered without an audit trail

• All user actions are recorded in ServiceNow and ERP

• Record of digital signatures for approvals and signoffs

• Data integrity & validation between ServiceNow and ERP to ensure no unauthorized data change

• Roll access control & authentication

Case Studies

The Make-to-Order (MTO) Work Order process is enhanced with ServiceNow’s FSM module, integrating with ERP systems to provide real-time access to BoM data, inventory, and parts details, ensuring greater accuracy and efficiency.

Automation of Make-to-Order (MTO) Process using ServiceNow FSM Module

The Make-to-Order (MTO) Work Order process is streamlined by automating creation, assignment, tracking, and closure within the Field Service Management (FSM) module of ServiceNow. Integration with ERP systems ensures real-time access to Bill of Materials (BoM) data, inventory status, and parts details. Configure workflows and business rules optimize resource allocation by assigning tasks based on technician availability, skills, and location. Automated notifications keep stakeholders informed, while dashboards provide real-time visibility into work progress. This automation enhances accuracy, reduces turnaround time, and improves overall service delivery.