Visit our Web Site

Sparta Systems, Inc. is the industry leader for global quality and compliance management solutions. TrackWise is Sparta System's quality management software solution, the web-based enterprise software application used by professionals the world over to manage quality, compliance issues and action items across the enterprise. It streamlines and improves your quality processes, reduces risk enterprise-wide, and covers regulatory affairs and reporting, all while increasing ROI.

With over 15 years of experience in highly regulated industries, Sparta Systems provides the quality management software solution that tackles your needs enterprise-wide. And with the domain expertise of our onsite solutions delivery support, you'll have the assistance needed each step of your entire project lifecycle.

TrackWise by Sparta Systems:

• Manages all quality processes in a centralized database.
• Enables site level, process level and role-based security.
• Streamlines workflow processes.
• Notifies users at milestones, when work is assigned and when tasks are due.
• Escalates past due items and provide visibility to common problem areas.
• Obtains information instantly using powerful ad hoc queries and personalized dashboards.
• Leverages powerful status reports and metrics using the integrated TrackWise and Crystal Reports report generator.
• Meets 21 CFR Part 11 requirements with support for electronic signatures and record and configuration level audit trail.
• Makes changes to the system seamlessly using point-and-click configuration tools.

TrackWise enterprise quality management software covers:

• Deviations
• Out of specifications (OOS)
• Nonconforming products
• Audits
• Process, validation, and documentation errors
• Nonconforming incoming materials
• Adverse trends
• Environmental and safety incidents
• Product
• Services
• Malfunction

Complaint handling and regulatory reporting, including:

• Investigations
• Product returns
• Sample tracking
• Electronic submissions of medical device reports (eMDRs)

Drug Safety, including:

• Regulatory assessments
• Adverse events reporting
• Medical coding
• Monitoring/Trending
• Product safety update reports
• Customer inquiries

CAPA (Corrective actions/Preventive actions)

Document management, including:

• Document control
• Automated document revision
• Comprehensive integration

Change control, including:

• Equipment
• Process
• Documents
• Batch/Materials
• Applications, systems, software
• IT infrastructure
• Validation

Audits, including:

• Compliance
• Computer, financial, and internal systems
• Third-party audits
• Supplier audits

Supplier quality, including:

• Approved supplier lists and scorecards
• Supplier qualification
• Supplier audits
• Material/Incoming inspection
• Supplier CAPAs, non-conformance, and documentation

Batch record/Batch release tracking

Regulatory affairs tracking, including:

• Correspondence
• Registrations
• Commitments
• Submissions
• Action items

Equipment management (Asset management)

Clinical trials workflow management, including:

• Protocol review
• Study, site, and patient tracking
• Study assessments
• Study exceptions/Deviations

Risk management, including:

• Internal assessments
• Issue management
• Loss event tracking
• Customer complaints
• Change management

IT service management

Environmental health and safety (EH&S)

Sample tracking

Employee training and qualifications