TrackWise Quality Management System Implementation & Modernization
Industry
Life Sciences / Pharmaceuticals
Service Provider
Paradigm Technocrats Pvt. Ltd.
Technology
TrackWise On-Premises (Classic) Version 11
Project Overview
A global life sciences organization required a comprehensive Quality Management System (QMS) solution to support regulated quality processes across multiple business functions and geographies.
The engagement focused on TrackWise implementation, version upgrades, workflow configuration, migration, validation, reporting, application development, and ongoing L2/L3 support. The objective was to modernize the platform while preserving existing business functionality, maintaining integrations, strengthening compliance, and providing reliable operational support.
Project Context
The engagement covered end-to-end TrackWise services, including:
- TrackWise implementation, configuration, upgrade, validation, and production support.
- Platform upgrades across multiple major TrackWise versions.
- Preservation of existing business functionality and connectivity with integrated platforms during upgrades.
- System Integration Testing (SIT), quality testing, documentation, and test evidence.
- Implementation and configuration of quality workflows for regulated business processes.
- Introduction of workflows to support environmental monitoring and excursion management.
- Development of compliance-focused solutions and enhancements.
- Provision of a cost-effective extended-hours service desk.
- L2 and L3 application support following ITIL-aligned practices.
- Migration of data and configuration between TrackWise environments.
- Reporting, notification, workflow, and application enhancements.
Our Role
Our team provided end-to-end TrackWise application services spanning implementation, development, migration, validation, support, and continuous improvement.
Quality Workflows Supported
The solution supported a broad range of regulated quality processes, including:
- Complaint Management
- Investigations
- Quality Events
- CAPA
- Deviations
- Audit Management
- Change Control
- Supplier Management
- Risk Assessment
- Correction
- Quality Assessment
- Task Management
- External CAPA
- Due Date Extension
- GMP Incidents
- Training Management
- Root Cause Analysis
- Change Management
- Master Data Management
- Action Items
- Critical Events
- Recall Management
- Effectiveness Checks
- Observation Management
- Internal, External, and Third-Party Audits
- Findings Management
- Annual Audit Planning
- Environmental Monitoring
- Excursion Management
- Other quality and compliance workflows
TrackWise Implementation & Upgrades
- Supported end-to-end TrackWise implementations and platform upgrades.
- Executed upgrades across multiple TrackWise releases while maintaining existing functionality.
- Ensured connectivity and interoperability with integrated enterprise platforms following upgrades.
- Supported SIT, quality testing, documentation, defect resolution, and release activities.
- Assisted with the adoption of newer platform capabilities to support evolving business and compliance requirements.
Workflow Configuration & Development
- Configured and enhanced TrackWise workflows based on evolving business requirements.
- Implemented workflow updates and configuration changes across multiple quality processes.
- Supported the development and maintenance of a comprehensive TrackWise application portfolio.
- Implemented solutions for quality events, investigations, CAPA, deviations, complaints, audits, change control, supplier management, and other regulated processes.
- Supported environmental monitoring workflows and excursion management.
Reporting & Notifications
- Developed single and multi-report solutions to provide business and quality insights.
- Configured TrackWise notifications and alerts for relevant stakeholders and management.
- Improved visibility into workflow status, quality events, actions, and operational performance.
Migration Services
- Performed PTP and related migration activities as part of TrackWise modernization initiatives.
- Planned and executed migrations with controlled validation and verification.
- Supported data and configuration transition while minimizing disruption to business operations.
Application Support
- Provided extended-hours L2 and L3 TrackWise application support.
- Delivered on-call support for critical application requirements.
- Served as a centralized point of contact across multiple TrackWise modules and workflows.
- Followed ITIL-aligned support practices for incident, request, problem, and change management.
- Worked closely with customer-facing service management teams to ensure effective issue ownership, escalation, and resolution.
- Maintained defined service levels and provided timely responses to application issues.
GxP & Life Sciences Expertise
- Provided resources with knowledge of GxP and regulated life sciences environments.
- Supported applications in accordance with applicable quality and compliance requirements.
- Applied industry best practices to application development, validation, support, and change management.
- Promoted knowledge sharing and cross-functional collaboration to improve service delivery.
Key Challenges Addressed
- Upgrading a business-critical TrackWise environment across multiple major platform versions.
- Preserving existing functionality and integrations during platform modernization.
- Supporting a large and globally distributed user community.
- Managing a broad portfolio of interconnected quality workflows.
- Maintaining application compliance within a regulated GxP environment.
- Providing reliable extended-hours support for critical quality applications.
- Migrating data and configuration with minimal business disruption.
- Balancing application enhancements, regulatory requirements, and operational support.
- Improving visibility through reporting, notifications, and workflow automation.
Benefits Delivered
Modernized Quality Platform
The TrackWise platform was progressively modernized to take advantage of newer platform capabilities and support evolving quality and compliance requirements.
Regulatory Compliance
The application environment was brought into alignment with applicable regulatory and GxP requirements through controlled configuration, testing, validation, documentation, and change management practices.
Smooth Migration & Upgrades
TrackWise upgrades and migration activities were executed through structured planning, testing, validation, and controlled implementation, minimizing disruption and implementation issues.
Reliable Application Support
An extended-hours L2/L3 support model provided timely incident response, effective troubleshooting, and structured issue resolution.
Improved Service-Level Performance
Defined support processes, ownership models, escalation procedures, and ITIL-aligned practices helped improve SLA adherence and the quality of ticket resolution.
Enhanced Quality Process Management
A broad portfolio of quality workflows enabled standardized management of complaints, investigations, CAPA, deviations, audits, changes, suppliers, risks, and other regulated quality processes.
Improved Visibility
Custom reports, multi-report solutions, and management notifications improved visibility into quality processes, workflow status, actions, and operational performance.
Cost-Effective Operations
A combination of centralized support, application development expertise, domain knowledge, automation, and knowledge sharing helped deliver quality application services in a cost-effective manner.Technology Landscape
Quality Applications | Enterprise ERP | Asset Management Applications | Computer System Validation (CSV) | Python | Database/Data Extraction | Test Case Management | CAPA | Deviations | IQ/OQ/PQ | 21 CFR Part 11 | GAMP | GxP | SDLC
Outcome
The engagement helped establish a structured, compliant, and efficient Quality Applications support model. Through a combination of application support, CSV expertise, testing, data validation, automation, and controlled decommissioning, the organization was able to maintain its systems in a validated state while improving operational efficiency and supporting ongoing application changes and modernization.