Sparta Systems, Inc.

Dec 01, 2006
By BioPharm International Editors
Volume 19, Issue 12

Company Description

Founded in 1994, Sparta Systems, Inc. is an enterprise software manufacturer that has developed innovative, 21 CFR Part 11 compliant Quality Management Systems (QMS) software for logging, tracking, reporting, and trending regulatory, commercial and operational regulatory requirements. The company has provided solutions to the life sciences industry since 1998. In addition to its US corporate, sales and service operations base in Holmdel, NJ, Sparta Systems, Inc. provides sales and services to Europe, Asia, and Australia through its subsidiary, Sparta Systems Europe, Ltd.

Biopharmaceutical Techniques Supported

cGxP Solutions for:
  • Deviations
  • Out of Specification
  • Investigations
  • Customer Complaints
  • Adverse Events/Drug Safety
  • Audits and Audit Observations
  • Change Control
  • Regulatory Commitments
  • Submission Tracking
  • Corrective and Preventive Action (CAPA)
  • Calibrations and Preventive Maintenance vClinical Trials Oversight
  • Environmental Health and Safety Issues
  • Risk Assessment
  • Document Management
  • Training Management

Products and Services

TrackWise software is the life sciences industry standard for managing global quality and regulatory compliance requirements, issues and related actions. TrackWise is a web-based, multi-user application that manages and tracks Nonconformance, Deviations/Incidents, Investigations, Customer Complaints, Change Management, Audits, Corrective and Preventive Actions (CAPA), Change Control, Supplier Quality, Training Management and other compliance requirements.

TrackWise is a 100% configurable application, enabling each organization to custom-configure the out-of-the box setup to meet its own specific needs. TrackWise allows companies to manage an unlimited number of business processes on a standard architecture without the need to purchase, install, and validate numerous application modules.

TrackWise streamlines and enforces SOPs through automated workflow, business rules enforcement and integrated report generation. TrackWise's built-in 24/7 business rule engine provides automated routing, notification, escalation, execution and distribution of management reports, and automated alerts based on developing trends. TrackWise interfaces seamlessly with data management systems including EDMS, ERP, CRM, and MES. TrackWise Content Management software enables organizations to manage controlled documents in a secure repository and reduce costs involved in document life cycle and retention management.

Sparta Systems has established an experienced professional services group that provides extensive integration services ranging from pre-sale consulting, to implementation, validation assistance, and training.

Holmdel Corporate Plaza
2137 Highway 35
Holmdel, NJ 07733





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