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DXC Tracker

by DXC Technology
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Regulatory SubmissionRegulatory SubmissionPharma Edition Available

Managed regulatory information management (RIM) solution for planning and tracking drug approvals, maintaining compliance, and streamlining submission and market authorization activities.

DXC Tracker is a managed regulatory information management (RIM) solution designed to help pharmaceutical companies plan and track drug approvals, maintain compliance, and streamline submission and market authorization activities. The platform is part of DXC's broader RIM Platform that securely integrates and connects compliance components to manage all regulatory affairs content, data, and workflows.

The platform features AI-powered capabilities including automated document classification (automatically classifies documents when imported) and document generation (creates documents in multiple languages using Generative AI). DXC states this AI integration reduces manual effort and accelerates regulatory submission processes.

DXC Tracker is available on AWS Marketplace, providing cloud-based deployment for pharmaceutical companies. The solution is delivered as a managed service by DXC Technology, combining software capabilities with professional services and regulatory expertise from DXC's life sciences division.

Customer Quantum Regulatory Solutions reduced processing time by up to 50% using DXC Tracker. DXC states the solution helps pharmaceutical customers accelerate the journey of new drugs to market through regulatory content management, submission tracking, and market authorization workflow automation.

Pharmaceutical Edition

DXC Tracker is purpose-built for pharmaceutical regulatory information management, focusing on drug approval workflows, regulatory submission tracking, and market authorization processes specific to the pharmaceutical industry.

Key Features & Capabilities

Core Capabilities

Regulatory submission planning and tracking for drug approval processes
Market authorization activity management and workflow automation
Compliance maintenance and regulatory affairs content management
AI-powered document classification - automatically classifies documents when imported
AI-powered document generation - creates regulatory documents in multiple languages using Generative AI
Regulatory content, data, and workflow integration across compliance components
Drug approval lifecycle tracking from submission through market authorization
Regulatory affairs data management and centralized content repository
Technical Specifications

DXC Tracker is available on AWS Marketplace, indicating cloud-based deployment on Amazon Web Services infrastructure. The platform is part of DXC's RIM Platform that integrates regulatory compliance components through secure connectivity for managing regulatory affairs content, data, and workflows.

The solution incorporates AI-powered capabilities built into the platform for automated document classification and multilingual document generation using Generative AI technology.

DXC Tracker is delivered as a managed service, meaning DXC Technology provides ongoing platform management, support, and maintenance as part of the solution. API availability, integration protocols, browser requirements, mobile access, and data residency options are undisclosed.

Pricing Information

DXC Tracker is available on AWS Marketplace with cloud-based subscription pricing. Specific pricing tiers, per-user costs, and contract structures are not publicly disclosed.

The managed service model includes ongoing subscription fees covering both software licensing and DXC's managed services. Pricing is based on deployment size, user count, service levels, and implementation requirements.

Implementation Details

DXC Tracker is delivered as a managed service solution, combining software platform capabilities with DXC Technology's professional services and regulatory affairs expertise. The managed service model indicates that DXC handles implementation, configuration, deployment, and ongoing platform management on behalf of customers.

DXC's life sciences division provides full-stack capabilities across applications, data, AI, and infrastructure. Implementation timelines, typical project durations, phased rollout approaches, and standard implementation methodologies are undisclosed.

Customer Quantum Regulatory Solutions achieved a 50% reduction in processing time using DXC Tracker. Implementation phases, timeline expectations, training programmes, change management support, and validation assistance are undisclosed. DXC Technology has more than 125,000 employees.

Strengths & Limitations

PharmaSpotter assessment from published vendor and third-party sources. No user reviews are on file for this product.

Strengths

Customer Quantum Regulatory Solutions achieved a 50% reduction in processing time using DXC Tracker. DXC states its AI-powered document classification and multilingual document generation, using Generative AI, accelerate regulatory submission processes and reduce manual effort. AWS Marketplace availability provides cloud-based deployment. DXC Technology's life sciences division offers full-stack capabilities across applications, data, AI, and infrastructure. The managed service model combines software capabilities with professional services for ongoing platform management and support.

Limitations & Open Questions

Compliance certifications are unconfirmed: FDA 21 CFR Part 11, GxP, and EU Annex 11. Pricing is undisclosed, requiring custom quotes from DXC sales. Implementation timelines and typical project durations are undisclosed. As a managed service from a large IT services provider, the solution may be better suited to enterprise customers than to small or mid-size pharmaceutical companies. DXC Technology sold its healthcare software solutions division to Dedalus in 2024, which may create uncertainty about long-term product roadmap and investment commitment. Third-party user reviews from G2, Capterra, or Gartner Peer Insights not available for independent validation of user experience.

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Notable Customers

Publicly disclosed pharmaceutical and biotech organizations

Quantum Regulatory Solutions
Vendor Information
DXC Technology logo

DXC Technology

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Ashburn, Virginia, United States
Founded 2017 (9 years)
1001-5000 employees
Public
Ticker: $NYSE: DXC
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