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Conformance1

Conformance1

Tools for conforming to standards, goals and processes

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TrackWise

$0.00

TrackWise by Sparta Systems is an enterprise quality management system (EQMS) designed to help organizations automate and centralize their quality processes. It enhances visibility across supply chains and streamlines compliance with regulatory standards such as FDA 21 CFR Part 11 and ISO 13485. The software is particularly suited for highly regulated industries, offering automation for audits, CAPA, change controls, and document management.

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SKU: SOFT-010 Category: Software
  • Description
  • Additional information

Description

Key Features and Benefits

  • Regulatory Compliance – Meets compliance requirements for FDA, ISO, and other industry-specific regulations.
  • Audit & Risk Management – Tracks audit processes and mitigates compliance risks.
  • Corrective and Preventive Actions (CAPA) – Manages CAPA processes to prevent recurring quality issues.
  • Document Control – Ensures version control and approval tracking for key compliance documents.
  • Training Management – Supports employee training and certification tracking.
  • Supplier Quality Management – Helps maintain visibility into supplier performance and compliance.
  • AI-Powered Decision Making – Utilizes AI to improve quality management and operational insights.
  • Scalability – Suitable for enterprise-level organizations managing complex quality systems.

Key Differentiators

  • Highly Configurable – Custom workflows allow businesses to align the software with their specific quality processes.
  • AI-Driven Enhancements – Supports proactive quality management through AI-augmented decision-making.
  • Enterprise-Level Implementation – Designed for large, multi-site organizations with stringent regulatory requirements.
  • Integration with Salesforce – TrackWise integrates with Salesforce to provide seamless quality management solutions.
  • Cloud-Based TrackWise Digital – Offers a cloud-based alternative for organizations transitioning to digital quality management.

Additional information

Software Features

Audit Management, Complaint Management, Compliance Management, Corrective and Preventive Actions (CAPA), Defect Tracking, Document Coding and Control, Equipment Management, ISO Standards Management, Maintenance Management, Risk Management, Supplier Quality Control, Training Management

Available Pricing Models

Per Month

Free Trial

No

Company Location

Hamilton, New Jersey, USA

Years in Business

25

Number of Employees

750

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