Enterprise Quality Management Solutions - TrackWise by Sparta Systems

TrackWise EQMS

TrackWise® by Sparta Systems: A Holistic Approach to Enterprise Quality Management
Organizations in highly regulated industries continue to face pressure to maintain the highest level of quality in every facet of their operations. Such pressure emanates from many different sources, including a wide range of international regulatory authorities, global customers and other key stakeholders. More recently, these same organizations have been faced with increasing economic pressures to increase operational effectiveness and efficiency while still being tasked with maintaining an optimal level of quality. The presence of software solutions in the quality arena has progressed gradually from a deployment of tactical point solutions to complete enterprise-level solution offerings. These integrated systems now provide dramatic benefits across broad functional areas for many organizations, enabling them to implement automated, highly interactive quality processes tailored to align with each organization’s specific products and business practices. The efficiency and effectiveness of these holistic quality systems are improved through interactive integration with other existing enterprise-level quality management software solutions. TrackWise software by Sparta Systems is an enterprise quality management solution (EQMS) that optimizes quality, ensures compliance and reduces costs for world-class clients across a range of industries. TrackWise software is the only enterprise quality management solution that offers the flexibility and configurability to adapt to company-specific business processes, enabling our world-class clients across a range of industries to define, track, manage and report on the core activities vital to their success. Manage all quality processes in a centralized database Enable site level, process level and role-based security Streamline workflow processes Notify users at milestones, when work is assigned and when tasks are due Escalate past due items and provide visibility to common problem areas Obtain information instantly using powerful ad hoc queries and personalized dashboards Leverage powerful status reports and metrics using the integrated TrackWise and Crystal Reports report generator Meet 21 CFR Part 11 requirements with support for electronic signatures and record and configuration level audit trail Make changes to the system seamlessly using point-and-click configuration tools
The following is a list of sample applications which have been implemented with the TrackWise Enterprise Quality Management Solution:
Exception Handling / Event Management • Deviations (aka, Discrepancies, Exceptions) • Out of Specifications (OOS), (aka Lab Investigations) • Nonconforming Product • Audit / Self Assessment findings / observations • Process Errors • Validation Errors • Documentation Errors • Nonconforming Incoming Materials • Observations (e.g., poorly lit work area) • Adverse Trends • Environmental Incidents • Safety Incidents • Product • Services • Malfunction (technical) Complaint Handling and Regulatory Reporting • Investigations • Product Returns • Sample Tracking • Electronic submissions of Medical Device Reports (MDRs) Drug Safety • Regulatory Assessments / Decision Trees • Adverse Events Reporting (MedWatch, Vigilance, ASR, E2B) • Medical Coding • Monitoring / Trending • Product Safety Update Reports • Customer Inquiries CAPA (Corrective Actions / Preventive Actions) • Corrections • Corrective Actions • Preventive Actions • Effectiveness Checks Document Management • Document Control • Automated Document Revision • Comprehensive Integration Change Control • Equipment • Process • Documents (SOPs, policies, manuals, marketing material, specifications, etc.) • Batch / Materials • Applications, Systems, Software (e.g., financial, validated systems) • IT Infrastructure • Validation • Label / Packaging Audits • Compliance • Computer Systems • Financial Systems • Internal Audits • Third-party Audits (e.g., FDA, customers, ISO) • Supplier Audits • Self Assessments		Supplier Quality • Approved Supplier Lists and Scorecards • Supplier Qualification • Supplier Audits • Material / Incoming Inspection • Supplier Non-conformance • Supplier CAPAs • Supplier Documentation Batch Record / Batch Release Tracking Regulatory Affairs Tracking • Correspondence • Registrations • Commitments • Submissions • Action Items Equipment Management (Asset Management) • Equipment • Validation Actions • Unscheduled / Unplanned Work Orders • Preventive Maintenance (Schedules & Events) • Calibrations (Schedules & Events) • Facility Work Orders Clinical Trials Workflow Management • Protocol Review • Study, Site, and Patient tracking • Study assessments • Monitoring Visits • Study Exceptions / Deviations Risk Management • Internal Assessments • Issue Management • Loss Event Tracking • Customer Complaints • Change Management IT Service Management • Change Control • Incident & Problem Management • Project & Action Item Tracking Environmental Health & Safety (EH&S) • Environmental Incidents • Safety Incidents • Audits & Inspections • Environmental Monitoring & Assessments • Occupational Health Services & Safety Management • Waste Management • Permit Tracking • Process Safety Management • Safety Metrics Reporting • Facility Risk Assessments • Action Items Sample Tracking • Lab Samples • Marketing Samples Employee Training & Qualifications

TrackWise® by Sparta Systems: A Holistic Approach to Enterprise Quality Management